Compliance Specialist Jobs

Job Title: Quality Assurance Associate Company: Isis Pharmaceuticals, Inc Location: San Diego, CA Description: Isis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, is the industry leader in the discovery and development of antisense drugs.   Isis was founded in 1989 in order to create advanced, novel medicines to treat complex and challenging diseases.  We are the leader in antisense technology and drug development with a pipeline of 22 drugs (developed by Isis and its partners). The Company establishes partnerships with large pharmaceutical and smaller biotechnology companies that provide dedicated and focused drug development and technology in order to maximize the potential of the technology we pioneered.  This strategy provides Isis with significant financial strength through a continuing stream of revenue from upfront license fees and milestone payments.  In this way, we remain a powerhouse in antisense technology, discovering new ways to treat disease while remaining small with a core, dedicated group of employees.  Isis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence.  Our founding goals have changed little in 20 years and our success is a direct result of our outstanding employees. We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team.  Join us and experience our unique culture while developing and expanding your career. We are currently seeking a highly motivated and talented individual to join our drug discovery research group as a Senior Scientist or Senior Research Associate.   QUALITY ASSURANCE ASSOCIATEThe Quality Assurance Associate’s primary responsibility will be to support Isis’ quality systems as they relate to the manufacturing and testing of Drug Substance (DS) and Drug Products (DP).  Principal duties include, but are not limited to: (1) providing general support for the Environmental Monitoring, Raw Materials, stability and water testing programs, (2) review of documentation and quality records, and (3) supporting the electronic Quality Management System (QMS). RESPONSIBILITIES:Collect and process samples for Environmental Monitoring (viable, non-viable, and surface samples) of cGMP manufacturing areas. Collect and process samples for TOC, conductivity, microbial, and endotoxin testing at the specified ports within the Purified Water system.Coordinate the required contract testing of water and environmental samples, and manage the receipt of test results.  Trend the data on a routine basis and compile annual summary reports.  Perform investigations into aberrant test results. Perform batch record review activities for reagent preparation, intermediates, DS and DP batch records and associated analytical data packages.Review the analytical data packages associated with stability testing time points for both DS and DP stability studies.  Recognize and communicate trends associated with the data over time.  Manage electronic entries into the QMS.  Provide follow-up for and track-to-closure all open entries in the system.  Prepare reports for Management Review detailing all Quality System metrics.Perform the QA/C release function for Raw and Starting Materials, including review of the lot file, completion of release documentation, and issuance of status labels.Review and approve forms associated with facility and equipment activation, calibration, maintenance, and alarm procedures.Provide back-up support for the review and approval of randomization lists for clinical trials, for the clinical trial unblinding process, and for editing and approval of computerized protocol databases.Other duties as assigned.REQUIREMENTS:Bachelor’s degree in a relevant discipline (e.g. chemistry, biology, engineering)·         Must have strong computer skills·         Effective communication (verbal and written), interpersonal and teamwork skills·         Previous Quality Assurance experience a plusAn ability to be productive and successful in an intense work environmentExcellent salary and benefits package offered.For more information on Isis and to apply for this position, please visit our website, www.isispharm.com.  Reference Requisition #252NO PHONE CALLS PLEASE.  PRINCIPALS ONLY. Isis Pharmaceuticals, Inc. is proud to be an EEO employer.

Job Title: Quality Assurance Compliance Specialist Company: CIS Inc Location: Lexington, MA Description: GMP Quality Assurance SpecialistPharmaceutical/Biotechnology  Company:                                Compliance Implementation Services (CIS) Status:                                                 Full Time  Relevant Work Experience:    5+ years Location                                 Lexington, Ma.Company Contact:                   Register to View -partners.com   Compliance Implementation Services (CIS), is a consulting firm that specializes in compliance strategies for the pharmaceutical and biotechnology industry. Our vision is to establish a culture of compliance throughout their entire organization using our years of industry experience. CIS has the depth of experience of the big consulting companies but offers an opportunity/alternative to utilize your experience in an entrepreneurial, aggressive, growth oriented working environment.  Our management team aggressively looks for fresh perspectives and insights vital to building a culture of innovation while maintaining a balance of lifestyle. Due to our continued growth, CIS currently has an open position in our Manufacturing Consulting Group.  The QA Specialist will be part of the quality team that entails the construction, commissioning, validation and startup of a new bioreactor facility. The individual's primary activities will include:           * Review and approval of User Requirement Specifications, Impact Assessments, Design Reviews, Validation protocols, Validation Reports, SOPs, and master Batch Records.           * Support of the establishment and execution of Quality Metrics and Quality Systems           * Attend Cross Functional meeting where QA input and oversight is needed.  Education & Experience Requirements:           * A minimum of a B.A. degree ( science preferred) with at least 4 years relevant experience executing or developing GMP quality programs in cGMP biotech and/or pharmaceutical environments                    * Pharmaceutical quality assurance experience ( biopharmaceutical a plus)           * Quality assurance or validation role on a new pharmaceutical facility project a plus.           * Knowledge and adherence to domestic and international GMP regulations, cGMP's, company policies  CIS is committed to developing employees who will make a tangible and continuous contribution to our clients’ performance and operations.  CIS offers the opportunity for serious professionals who feel that their contributions will make an impact in a non-political, results oriented culture while growing professionally and financially and maintaining a balanced lifestyle.      This position is a full time employee position with benefits - compensation includes sign-on bonus if candidate can start the first week of December.  For immediate consideration, send Resume to: Register to View -partners.com

Job Title: Temp, Quality Assurance Associate III Company: Stryker Biotech Location: Hopkinton, MA Description: The Temp, Quality Assurance Associate III is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all Stryker Biotech products. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support records. Participates in the internal and vendor qualification programs and makes vendor assessment recommendations.• Reviews all manufacturing and support records to certify compliance with specifications and procedures.• Releases product based on Quality Assurance record review and approval by QA Manager.• Performs regular internal audits of Stryker Biotech Manufacturing facilities as a lead auditor.• Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issues.• Performs vendor audits as scheduled.• Reviews and assesses Deviations, including evaluation, tracking, follow-up, and reporting / trending.• Reviews and approves Validation / Technical Reports.• Reviews and assesses Corrective and Preventive Action Reports• Participates in Regulatory Inspections.• Other duties as assigned. REQUIREMENTS - QUALIFICATIONS: Temp, Quality Assurance Associate III Bachelor’s Degree required, a scientific discipline preferred.• A minimum of 5 years of GMP-related experience in a pharmaceutical or biotechnology company, with 3 years of direct QA experience.• Experience in a licensed drug or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred.• As applicable, experience with Quality Assurance oversight and support for all phases of Clinical Trials & Clinical Operations.• As applicable, experience with Independent Quality Assurance Contract manufacturing oversight.• Excellent written and verbal communication and negotiating skills are required.• Strong planning and organization skills, with flexibility for changes in work priorities.• Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken.• Normally receives no instructions on routine work, and general instructions on new assignments. Determines and develops approach to solutions.• Ability to work on complex Quality projects where analysis of data requires evaluation of identifiable factors.Stryker Biotech

Job Title: Compliance Specialist - Packaging Company: Smith Hanley Consulting Group Location: Marietta, PA Description: Company Overview:Founded nearly 30 years ago, Smith Hanley Consulting Group is a specialized services organization offering recruiting, consulting, outsourcing and related services to the pharmaceutical and life science organizations.  As part of inVentiv health, Inc. (NASDAQ:VTIV), the leading provider of clinical, communications and commercialization services to the global pharmaceutical, life sciences, biotechnology, financial services and other industries, we offer our consultants access to a wealth of opportunities unmatched in the industry today.Job Description: This position will provide compliance assurance through the review of  records to include batch documentation, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents; leading investigations, initiating deviations and determining corrective action.  As a member of the Value Stream Packaging & Logistics team, be co-responsible for the site and the department results. Ensure personal objectives are aligned with site goals and objectives.PRINCIPLE JOB DUTIES: ·        Lead cross functional team to investigate deviations. Prepare reports from outcome of investigations.·        Perform root cause analysis, FMEA’s and collaborates with the Industrial Excellence team to use other tools to address manufacturing concerns.·        Review and assemble batch documentation testing results, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents.·        Assess the impact of discrepancies on products or processes and recommend product disposition.·        Determine robust corrective actions and/or commitments.·        Ensure timely completion of manufacturing discrepancy commitments.  This includes writing, revising, or coordinating the efforts for change controls, standard operating procedures, batch documentation and training documentation.·        Initiate manufacturing deviations using a qualified system such as SAP.·        Track, trend, and evaluate manufacturing discrepancies and work to determine root causes.  This includes tracking and trending using a visual factory.·        Prepare and track change controls to make improvements outside of deviations.·        Maintain and track the CAPA’s for the manufacturing department. ·        Interact and coordinate with appropriate personnel including manufacturing, QA/QC, regulatory, technical services, etc.·        Communicate immediately with QA and Operations management for all manufacturing discrepancies that impact product quality or safety.·        Develop internal audit schedule (including area to be audited) on a yearly basis and communicates the schedule to the site Quality organization. ·        Write clear concise summaries of investigations, product impact assessments, and commitments.·        Represent the manufacturing department at the site change control meetings.·        Participate in the Process Qualifications during the start-up phase to support any deviations that are generated.·        Interact with external regulatory authorities as needed during routine and non routine audits.·        Provide classroom training to manufacturing operations as requested.·         Participate in site Industrial Excellence initiatives.·         Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.  Adhere to all GSK safety guidelines and procedures.·         Adhere to all GSK Quality Management System (QMS) policies and procedures as applicable for functional area.·         Work on any assignment as directed.·         Cost: Demonstrate a cost conscience mindset and reduce waste in order to deliver profitability.  ·         Reporting: Ensure that all relevant information relating to all functional responsibilities and activities are tracked, captured and forwarded in due time to the management. ·         Quality: Ensure all activities are executed following quality and regulatory standards.  Promote a quality mindset and quality excellence approach to all activities.  ·         EHS: Ensure all activities are executed including EHS standards and promotes a safety culture.  ·         Act as change agent: Personal responsibility for supporting the value stream way of working at GSK Marietta.  Ensure that communication flows cross-functionally and that a purely functional focus (silo) is not allowed to develop.  Deal positively with change, demonstrating the ability to maintain high personal performance levels as the organization evolves.  Is also a positive influence on others' ability to adapt to change.  ·         Service to other Areas/Departments/Teams: Actively apply customer relationship management to provide pro-active response to customer needs. Maintain, develop and work in close relationship with all defined customers of the role.Minimum Requirements: ·        B.S or B.A in a technical discipline, preferrably Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy.  Degree in other discipline if sufficient technical depth has been achieved from profressional experience.·        Minimum of 3 years pharmaceutical experience investigationg manufacturing deviations either in a QA or manufacturing role; preferrably in Biologics Secondary Manufacturing.·        Working knowledge of pharmaceutical facilities, equipment and systems.  Including  a technical understanding of industry and science practices related to the business in order to apply  knowledge to daily activities.·        Demonstrated problem solving and investigational skills. ·        Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficent to apply to quality operations and compliance.·        The ability to commuincate both verbally and in writing with all levels both inside and outside of the oragniziation.  The ability to clearly write technichal documentation as necessitated by regulatory agancies an internal policy.·        Ability to establish and maintain working relationships with staff and the abiliy to analyize data and implement changes.  ·        Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA.  Ability to work in a high complex matrix environment.·        Able to prioritize and decide appropriate course of actions and to effectively  implementing decisions.·        Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.·        Able to maintain attention to detail while executing multiple tasks.·        Able to perform job duties with minimal supervision.·        Sense of urgency, flexibility and accountability.·        Intermediate computer skills required.·        Stay current on developments in the field and GSK-Bio Standards.·        Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines. , Not Specified

Job Title: Compliance Specialist, Issues Management Company: Genentech Location: South San Francisco, CA Description: Employer Information About Genentech n/a View all our jobs Job For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to develop novel medicines for serious and life-threatening diseases. Today, Genentech is among the world’s leading biotech companies, with multiple therapies on the market for cancer and other serious medical conditions. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset. The following opportunity exists in our South San Francisco, CA, headquarters: Compliance Specialist, Issues Management Responsibilities: The Compliance Specialist will manage notification of Potential Quality Issues specific to U.S. Genentech/Roche products for Product Complaints requiring escalation to the Technical Review Committee (TRC) and/or Action Committee (AC). He/she will manage New Drug Application-Field Alert Report and Biological Product Deviation Report activities to ensure appropriate actions to prevent non-compliant status and also manages the product recall process as required. The candidate will act as the Quality point of contact for the U.S. Anti-Tampering Team and Extended Anti-Tampering Team. In addition, he/she lead and coordinate TRC and AC meetings.

Job Title: Temp, Quality Assurance Associate III Job Company: Stryker Location: Hopkinton, MA Description: Temp, Quality Assurance Associate III Job Job Title: Temp, Quality Assurance Associate IIIDivision: Stryker BiotechLocation: (Country - State) United States - MassachusettsCity or Sales Region: HopkintonBusiness Function: Regulatory/Quality/Clinical AffairsShift: 1stEducation and/or Special Training: See QualificationsJob Description: The Temp, Quality Assurance Associate III is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all Stryker Biotech products. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support records. Participates in the internal and vendor qualification programs and makes vendor assessment recommendations. Reviews all manufacturing and support records to certify compliance with specifications and procedures. Releases product based on Quality Assurance record review and approval by QA Manager. Performs regular internal audits of Stryker Biotech Manufacturing facilities as a lead auditor. Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issues. Performs vendor audits as scheduled. Reviews and assesses Deviations, including evaluation, tracking, follow-up, and reporting / trending. Reviews and approves Validation / Technical Reports. Reviews and assesses Corrective and Preventive Action Reports Participates in Regulatory Inspections. Other duties as assigned.Qualifications/Work Experience: Bachelor's Degree required, a scientific discipline preferred. A minimum of 5 years of GMP-related experience in a pharmaceutical or biotechnology company, with 3 years of direct QA experience. Experience in a licensed drug or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred. As applicable, experience with Quality Assurance oversight and support for all phases of Clinical Trials & Clinical Operations. As applicable, experience with Independent Quality Assurance Contract manufacturing oversight. Excellent written and verbal communication and negotiating skills are required. Strong planning and organization skills, with flexibility for changes in work priorities. Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken. Normally receives no instructions on routine work, and general instructions on new assignments. Determines and develops approach to solutions. Ability to work on complex Quality projects where analysis of data requires evaluation of identifiable factors.Percent Travel Required 5-10%Requisition ID: 11181BR

Job Title: Training & Compliance Specialist Company: Johns Hopkins University Location: Baltimore, MD Description: General Description:This position supports the mission of the Office of the JHU Animal Care and Use Committee to assure university compliance with federal regulations and policies governing the use of animals in research, and to assure that the animal program remains fully accredited. Will work with the Senior Training and Compliance Specialist to: - Coordinate and conduct or assist with routine inspections of animal housing and care and use areas; - Participate in teaching AALAS certification preparation classes or seminars/workshops; - Participate in development of new materials for training; - Carry out comparisons of grant proposals and corresponding approved ACUC protocols; - Prepare reports, as assigned; - Assist with investigation of animal welfare concerns and alleged noncompliance issues; - Assist with administrative functions of the ACUC Office as needed; - Other duties as assigned. Qualifications:Bachelor's Degree required in Biology, Zoology, Animal Science, Psychology, Behavioral Biology or other related field. Some experience in laboratory animal research, laboratory animal care, or a training & compliance position is required. Excellent verbal and written communications skills required. Must be computer literate, and able to work with office management, presentation and training software. Excellent interpersonal skills required. Must be able to communicate tactfully. Ability to work cooperatively with others required. Attention to detail required. Will need to become familiar with federal regulations and policies regarding the roles and responsibilities of Animal Care and Use Committees if not already conversant. One year related experience preferred. LAT or LATG certification or veterinary technician training strongly preferred.Job Type: Full Time

Job Title: Label License and Compliance Specialist Company: Applied Biosystems Location: Carlsbad, CA Description: Life Technologies has an immediate opportunity available for a Label License  Specialist in the License Management and Contract Compliance team at our Carlsbad, CA headquarters.  This newly created position will be responsible for establishing a consistent limited use label license policy for Life Technologies, including establishing processes associated with that policy, developing standardized limited label license language that best protects the company’s long and short term out licensing options and complies with the company’s in license related product labeling requirements, and implementing that policy across the entire company, for current as well as new products. Close interaction with Marketing, Product Management, New Product Introduction, R&D, M&A and In and Out Licensing will be a critical part of the role. The position will also work with others in the LMCC team to coordinate efforts to ensure that the company complies with with certain non-financial license obligations associated with in licenses and acquisitions, such as preparation of product development reports, and willsupport the LMCC auditing function as appropriate with regard to non-financial obligations related to OEM agreements and out licenses Responsibilities include:  Developing a new limited use label license policy, in collaboration with out licensing, in licensing and legal. Developing standardized limited use label licenses for use across the company, in combination with the new policy. Working with product management, marketing, IT, operations, new product introduction and other functions as appropriate, to develop a process to implement the new policy and manage it going forward for all new products and services. Develop a plan to evaluate all current products and implement the policy with regard to those products. Develop and implement a process in coordination with Marketing to ensure that all marketing materials comply with this process. Work with others in the LMCC team to develop a process for tracking non-financial obligations related to in licenses and acquisitions and overseeing the implementation of that process, in collaboration with appropriate business units and functions (including R&D, product management and others as appropriate). Work with others in the LMCC team to support the LMCC Auditor by evaluating selected out licensees and OEM customers to determine whether or not such parties are in compliance with non-financial obligations in contracts, such as product marking or field of use limitations.   Education:   A masters or higher degree in a biological science is required. Knowledge of molecular biology or cell biology strongly preferred.  . Skills/Knowledge/Experience:   A minimum of three years of experience in a Life science company or technology transfer office at a university or research institution is required.   Excellent written and verbal English language communication skills are required. Experience in the interpretation of standard business terms in license agreements or other contracts, such as might be acquired through experience in business development or technology transfer, is required. Legal experience, such as might be obtained working in a law firm or with an attorney or patent agent in a life science industry is desirable. A legal degree is not required. The ability to work effectively in a fast-paced interdisciplinary team is essential.  This role requires the ability to multi-task, and strong attention to detail. A collaborative, can-do attitude is critical.                                                 Life Technologies is proud to be an equal opportunity employer committed to hiring a diverse and inclusive workforce

Job Title: Compliance Specialist - Warehouse Company: GlaxoSmithKline Location: Marietta, PA Description: GSK Biologicals, N.A. with our global quest to improve the quality of human life by enabling people to do more, feel better and live longer, is seeking a Warehouse Compliance Specialist for our vaccine manufacturing facility in Marietta, PA.The Warehouse Compliance Specialist will provide compliance assurance through the review of batch documentation, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents. The role will also lead investigations, initiating deviations and determining corrective action. Responsibilities include:• Perform root cause analysis, FMEA’s and collaborate with the Operational Excellence team to use other tools to address potential deviations. Initiate deviations using SAP.• Assess the impact of discrepancies on products or processes and recommend product disposition.• Lead cross functional team to investigate deviations. Write clear concise summaries of investigations, product impact assessments, and commitments. Prepare reports from outcome of investigations.• Determine robust corrective actions and/or commitments.• Maintain and track the CAPA’s for the warehouse.• Prepare and track change controls to make improvements outside of deviations. Represent the warehouse at the site change control meetings.• Ensure timely completion of manufacturing discrepancy commitments. This includes writing, revising, or coordinating the efforts for change controls, standard operating procedures, batch documentation and training documentation.• Track, trend, and evaluate discrepancies and work to determine root causes. This includes tracking and trending using a visual factory.• Develop internal audit schedule (including area to be audited) on a yearly basis and communicates the schedule to the site Quality organization.GSK Biologicals in Marietta is a beautiful community located along the Susquehanna River in Lancaster County, Pennsylvania. Our employees enjoy the proximity to larger metropolitan areas and benefit from more affordable housing, excellent school systems, and access to a multitude of recreational activities and the more relaxed lifestyle that the area has to offer.GlaxoSmithKline REQUIREMENTS - QUALIFICATIONS: Compliance Specialist - Warehouse If you believe you can be successful in a challenging vaccine manufacturing environment with a global organization and possess all of the following minimum qualifications, we encourage you to apply immediately:• B.S or B.A in a technical discipline, preferrably Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy. Degree in other discipline if sufficient technical depth has been achieved from profressional experience.• Minimum of 3 years pharmaceutical (consumer, pharma/biopharma, medical device, or vaccines) experience investigating deviations either in a QA or manufacturing role.• Demonstrated problem solving and investigational skills.• Demonstrated experience in quality systems to include deviation investigation, CAPA, change controls, and procedures development & management.• Fully versed in GMP’s, NIH and WHO Guidelines, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance.• Demonstrated ability to exhibit: flexible thinking; a willingness to develop oneself and others; the ability to build and maintain relationships; be customer focused; enable and drive change in a dynamic work environment; and exhibit a continuous improvement mindset.• Computer skills in Microsoft Office applications and the ability to quickly and easily learn new applications.Additionally Preferred candidates will possess:• Prior experience with licensed biopharmaceutical or biological products.• Prior experience with SAP in an pharmaceutical manufacturing environment.• Lean Six Sigma Training / Certification.• Prior Quality Systems experience investigating deviations for a vaccine manufacturing facility.GSK Biologicals, N.A. is committed to being the Best Place for the Best People to do their Best Work. This is accomplished through our Total Reward competitive compensation package, our employee performance and development planning and our diverse, challenging, and innovative work environment.

Job Title: Pharmacovigilance Compliance Manager Company: Baxter International Inc. Location: Deerfield, IL Description: Job Title:Pharmacovigilance Compliance Manager Company:Baxter International Inc. Location:Deerfield, IL Status:Full-Time, Employee Job Category:Pharmaceutical/Biotech     Company:Baxter International Inc. Reference Code:41346BR     Pharmacovigilance Compliance Manager Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. This role is part of the GPV Process, Compliance and Education organization. This role is responsible for driving Pharmacovigilance compliance based on expectations and/or requirements of regulatory agencies, internal processes, and external business partners. This role has responsibility for creating relevant internal standards (metrics) by which to measure compliance in other GPV sub-functions. Monitors existing standards to ensure compliance and consistency in implementation. Reviews the effectiveness of GPV process, compliance and organizational standards. Implements and optimizes Global Pharmacovigilance processes related to the function’s compliance with regulatory reporting timelines and Baxter’s Quality policies, while ensuring the highest possible level of report quality. Responsibilities include, but are not limited to the following: Drives Pharmacovigilance compliance based on expectations and/or requirements of regulatory agencies, internal processes, and external business partner obligations. Ensures GPV process and training standards are effectively implemented, appropriately documented and consistent with departmental, RAPV organizational, corporate and regulatory requirements. Develop, evaluate and monitor internal/external compliance metrics. Create routine effectiveness checks of GPV case files, controlled documents, training records, etc., to identify process improvement opportunities. Works closely with PV Technology to ensure safety systems are consistently aligned with current processes. Monitors, reviews and makes recommendations regarding processes and guidelines with emphasis on compliance standards. Driving initiatives to ensure pharmacovigilance awareness and competence within the company as well as with external business partners. Work with key stakeholders to define and ensure compliance with global business and regulatory requirements. Product/Process Quality Standards Establish compliance with pharmacovigilance procedures and systems and demonstrate leadership in assigned areas of responsibility. Communication with Regulators/Customers Execute PV strategy to be in compliance by training and creating processes. Submission/Project Management Effectively demonstrates and establishes an environment that focuses on continuous improvement. Excellent analytical and process skills and the ability to apply these skills to Baxter's GPV organization. Excellent communication, consulting, customer service and problem solving skills. Must be detail oriented, have the ability to meet deadlines. PC skills to include solid working knowledge of Microsoft Office software (Excel, Word, PowerPoint * MS Project required). Excellent time management skills. Strong leadership qualities Management experience including project management experience with the demonstrated ability to manage multiple projects simultaneously. Strong interpersonal skills and ability to interact with all levels of the organization Ability to work well in a matrixed, global team environment Bachelor's degree, preferably in a healthcare-related field Minimum of 5 years pharmacovigilance work experience. Project management, process improvement and/or training experience required Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.