Compliance Specialist Jobs

Job Title: Quality Assurance Associate Company: CMC ICOS Biologics Location: Seattle, WA Description: Type: Temporary position Duration: 6 Months Responsibilities Administerthe Supplier Qualification Program Review Supplier Questionnaires Ensure Quality Agreements are in place with Suppliers Maintain the audit database and Approved Supplier list Perform internalaudit functions to comply with all applicable regulatory requirements, company procedures and industry standards, including planning, scheduling, auditing, report writing and corrective action tracking and trending. Requirements Bachelors degree in scientific or a related field Minimum of 8 years experience in biotech or pharma required. GMP QA experience required. Auditing skills including experience in performing system/process audits. Ability to manage multiple projects. Experience with technical writing preferred. Excellent written and verbal communication and interpersonal skills. Good organizational skills, attention to detail, and the ability to multi-task required. CMC ICOS Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE

Job Title: Regulatory Affairs/Compliance specialist. (Pharma/Biotech). Pay:$33/hr W2. Company: Nauticasoft Location: Waukegan, IL Description: Regulatory Specialist /Compliance Specialist. Pharma/Biotech. Pay:$33/hr W2. Nauticasoft invites resumes for a Regulatory Specialist /Compliance Specialist with Pharma/Biotech background. Please note this position is based at Waukegan, IL. We welcome candidates from neighbouring states but they need to relocate on their own and must be able to attend an in-person interview if requested. Location: Waukegan, IL. This is a W-2 position only. 1099 or corp-to-corp candidates are NOT eligible for this position. No solicitations or 'hotlists' please. H1b's please excuse. Pay:$33/hr on W2. Candidate must be legally authorized to work on W2 with out sponsorship. ( EOE) If you meet the below skills please send your resume to Register to View Primary Function / Primary Goals / Objectives: Develops and maintains Core Data Sheets and coordinates review and approval of these documents with changing regulatory environments. Leads discussions to ensure global consistency of labeling. Major Responsibilities: -Independently completes labeling activities assigned. Able to participate and contribute to labeling decisions within cross functional teams -Assimilates data and effectively defines labeling strategies Seeks expert advice and technical support data needed to complete assigned labeling projects -Develops strategic labeling responses, within cross-functional team -Maintains accurate files of labeling change history and associated documents -Assesses and approves change request for labeling documents -Attends team meetings, reviews materials, authors documents, meets submission timelines -Works with safety groups on safety issues and leads discussion on safety related labeling changes. Understands and supports regulatory implications of product safety profile. -Independently will provide labeling support to affiliates including pre-approvals, renewals, and competitive analysis. . Assists in training of new personnel and in the development of department processes/policies. Education: Bachelor of Science degree. Advanced degree desired. Background: 3-5 years relevant experience with 1-2 years of labeling or related regulatory experience Accountablility / Scope: Some supervision of projects and daily priority setting required. Able to define strategy with some supervision. 3-5 years of broad-based professional business work experience and strong computer user skills. Tasks would generally involve a mix of several skills and abilities used in finance, sales/customer service, operations, HR, marketing/communications, or R&D, possibly a concentration in more than one business discipline and not necessarily a mastery of any one area. Could be team lead or light supervisory responsibilities or charged with coordinating tasks or information in a deadline related setting. Nauticasoft is an equal opportunity employer. We welcome and encourage employee diversity. To learn more please visit us at www.nauticasoft.com an

Job Title: Compliance Specialist/Sr. Compliance Specialist Communication & Training Company: Genentech, Inc. Location: South San Francisco, CA Description: ABOUT US 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. Our employees cite the chance to make a difference in the lives of patients as the number one reason they enjoy working at Genentech. In hiring new employees, we look for people who are inspired by this mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. 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 facility: Compliance Specialist/Sr. Compliance Specialist Communication & Training Job ID: Register to View South San Francisco, CA RESPONSIBILITIES: Compliance Specialist/Sr. Compliance Specialist- Communication & Training RESPONSIBILITIES: The Compliance Specialist/Sr. Compliance Specialist - Communication & Training works closely with other members of the Healthcare Compliance Office (HCO) Training Team and other HCO teams to develop the annual healthcare compliance training strategy and specific compliance training initiatives for Genentech's Sales, Marketing, Medical Affairs and Managed Care organizations. This position reports to the HCO Associate Director of Compliance Training. - Responsible for understanding the Genentech organization, particularly corporate policies and guidelines, as well as internal organizational dynamics. - Collaborate with project leads and decision makers and engage appropriate stakeholders to achieve project objectives (training & policy related). Stakeholders include, but are not limited to: Healthcare Law Group, Commercial Regulatory Affairs, Commercial Training & Development, HCO, Sales, Marketing, and Commercial Business Operations. - Lead or participate in Policy teams - Track and report project progress via a variety of communication vehicles including PowerPoint presentations. - Participate in projects designed to improve training and learning throughout Genentech, applying standards, performing needs assessments and evaluations, designing, developing, and delivering training, as appropriate. - Responsible for translating policy guidelines into easy-to-follow training materials. - Analyze, design, develop, deliver and evaluate training solutions, including interactive instructor-led courses, self-instruction, online learning, job aids, and other performance-based solutions. - Create metrics and assess impact of training programs - Edit training materials for formatting, flow, readability, and educational effectiveness. - Conceptual planning, implementation, and execution of training plans & policy roll-out, including key message development, training program execution, training internal communications plan development and execution. - Assist in creating metrics and assess impact of training programs. - Effectively manage outside vendors that assist with training and policy initiatives. - Assist in Marketing compliance programs to ensure awareness and proper utilization. REQUIRED QUALIFICATIONS, CORE COMPETENCIES, AND EXPERIENCE: - BS/BA. MBA or MA/MS preferred. - 5 or more years experience in the pharma/bio-tech field - 3 years (Compliance Specialist) - 5 years (Sr. Compliance Specialist) experience training Sales and Marketing teams, or in compliance training is strongly preferred. For Compliance Specialist: - Keen understanding of life sciences industry trends related toLegal, regulatory and compliance areas, including the Federal and State Anti-kickback statutes, off label promotion, PhRMA Code on interactions with healthcare professionals (HCPs), state Marketing laws, FDA regulations and opinions, and related issues. - High competency in the following areas: priority setting, multi-tasking, planning, process and project oriented, oral and verbal communication, strategic ability, organizational agility, effective decision making, results oriented, team participation, time management, ability to work under pressure and with tight deadlines. - Demonstrated ability to collaborate and negotiate business solutions in a complex and fast paced matrix environment. - Excellent written and oral communication skills, with a proven ability to communicate effectively with senior-level executives. - Strong meeting management and group process facilitation skills, with ability to structure small- and large-group meetings to achieve pre-defined objectives. - Strong Customer Service orientation. - High degree of customer-focused sensitivity toward internal and external customers and business partners. - Ability to work independently and as part of a team. - Strong analytical and problem solving skills, paired with strong partnering and consulting skills. - Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization. For Sr. Compliance Specialist (in addition to those listed above): - Strong partnering and performance consulting skills, and works well in a team environment. - Capable of seeing the big picture and determining long-range planning. - Demonstrated ability to develop technical and conceptual training material for both large and small audiences in a variety of delivery methods. - Continuously improves learning and development experiences by integrating new methods, approaches and content. - Takes initiative and has the ability to work without appreciable direction. - Understands and abides by scope of decision making authority. - Makes decisions with minimal delay as appropriate. - Excellent judgment - sizes up situations accurately in own area of work and looks beyond immediate problems to consider underlying causes and seeks to address these. DIVISION: Legal REQUISITION NUMBER: 1 Register to View Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. To learn more about our current opportunities, please visit: http://careers.gene.com and reference Req. # Register to View . Please use ?Web ? BAJobs? when a source is requested. Genentech is an Equal Opportunity Employer.

Job Title: REGULATORY AFFAIRS, EDUCATION, SAFETY & LAB COMPLIANCE MANAGER Company: University of California San Diego Medical Center Location: San Diego, CA Description: San DiegoDepartment: Clinical Labs EducatorPayroll Title: Scientist Spec Clin Lab Sr, Sup. Filing Deadline: 03/23/10Extended Deadline: 08/31/10Salary commensurate with experienceOne (100%) full-time position with benefits starting on the date of hire. The Regulatory Affairs, Education, Safety & Lab Compliance Manager will: Report to the Administrative Laboratory Director, The Manager for Regulatory Affairs, Education, Safety, & Laboratory Compliance provides leadership and expertise to direct a department wide quality and compliance program for the Clinical and Pathology Laboratories of UCSD Health System. Direct a quality/compliance unit and QA support functions for the implementation and maintenance of Quality System essentials throughout the department. Oversee and administers the UCSD Clinical Lab Scientist Training Program. Oversee and administers staff training and competency programs. Ensure compliance with all guidelines, standards, regulations, and laws of the pertinent licensing, accrediting, credentialing, and regulatory agencies. Ensure adherence withUCSDinternal guidelines and policies for safety, environment of care, and corporate compliance. The Regulatory Affairs, Education, Safety & Lab Compliance Manager must: Have a current Clinical Laboratory Scientist or appropriate subspecialty license issued by the State of California, Department of Public Health. Bachelor's degree in one of the Clinical Laboratory Sciences (microbiology, biology, chemistry, or related fields) required. Minimum of 3 years in quality/compliance role. Supervisory or Management experience preferred. Demonstrate appropriate level of theoretical/practical knowledge of disciplines to which assigned. Have the ability to function as a competent trainer and teacher and effectively oversees this function when performed by subordinates; includes training of staff, CLS Program students, others. Understand, comply, and actively supports all guidelines as set forth in the Laboratory Compliance Program and the UCSD Healthcare Corporate Compliance Program and ensures compliance within area(s) of responsibility. Must be able to work all shifts, week-ends, holidays, overtime, and at various locations as necessary in accordance with operational needs. Excellent communication skills with the ability to communicate clearly both verbally and in writing and be able to articulate complex ideas for all levels of audiences. Be a self-starter who is accountable and requires minimal direction and supervision; a person who is open to new ideas; and a creative and flexible individual who is comfortable working in a large, complex organization. Possess the personal characteristics of professionalism, credibility, commitment to high standards, innovation, discriminating judgment and accountability.University of California, San Diego (UCSD) Health System is the only university-based medical facility in San Diego, providing leading-edge care in patient care, biomedical research, education, and community service. We have two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Center, the Sulpizio Family Cardiovascular Centerand several outpatient clinics. UCSD Medical Center, Hillcrestis also a designated Level I Trauma Center and has the only Burn Center in the county. U.S. News and World Report's 2009 annual "America's Best Hospitals" report ranks UCSD Medical Center among the best in the nation in six specialty areas, more than any other hospital in San Diego County. We invite you to join our dynamic team!Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

Job Title: Compliance Mgr Company: AMGEN Location: Seattle, WA Description: The purpose of this position is to provide independent and objective compliance advice and oversight to the business in support of regulatory filings and key R&D activities and to provide actionable compliance information to management within R&D with a major focus on Good Laboratory Practices for the support of Amgen s preclinical programs. This position will require 25% to 40% of travel. Key responsibilities include: Plan, conduct and report routine compliance audits Follow-up on corrective actions to resolution Identify compliance risks Provide compliance advice to the business to support regulatory filings and other key R&D activities Participate in departmental projects and initiatives Represent the department at assigned area meetings Assist in creating and/or presenting training sessions Collaborate with other Amgen compliance functions as appropriate Support Regulatory Agency inspections Participate in directed compliance audits as needed Communicate compliance metrics to program teams Contribute to department SOPs, user manuals, audit checklists and templates Maintain knowledge of current regulatory, GCP, GLP and/or PV practices/issues as applicable Represent Amgen on appropriate industry and professional forums Provide coaching/mentoring to staff Basic Qualifications Bachelor s degree Minimum of 1 year GLP auditing experience Minimum of 4 years in related pharmaceutical/healthcare industry Knowledge and application of GLP regulatory requirements Knowledge of GLP auditing principles Understanding of preclinical and translational sciences processes Preferred Qualifications Bachelor s degree in Science (biology, toxicology, biochemistry, chemistry or related fields preferred) Experience supporting regulatory authority inspections of preclinical and/or clinical research activities Knowledge and application of GCP and/or PV regulatory requirements Knowledge of GCP and/or PV auditing principles Understanding of clinical development and/or PV processes With the emphasis on the following key competencies: Strong verbal and written communication Ability to work/collaborate efficiently in teams Ability to manage time well in multi-task/ priority-shifting environment Great interpersonal skills Results Oriented Analytical Strong leadership abilities Ability to mentor others

Job Title: Compliance Specialist Principa Company: Genzyme Corporation Location: Allston, MA Description: Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzyme's people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortune's list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzyme's local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success. The QA Compliance Specialist will support activities to ensure site GMP and general compliance readiness. The specialist will be part of the Compliance Team that works with Bulk and Fill Finish Quality Assurance, management and peers in other functional areas, primarily Therapeutic Manufacturing, Quality Control, Regulatory Affairs and Corporate Compliance. The position contributes to the assurance of Allston inspection readiness in alignment with global good manufacturing practices, regulatory compliance requirements and current industry/Genzyme policy and guidance. Key responsibilities/requirements of the job include: Conducting internal audits for GMP compliance and internal Genzyme standards Generating audit reports Tracking and trending observation CAPAs Conduct follow-up to non compliant issues Data trending Participating in external regulatory/customer and CQC audits -support the timely closure of audit responses and CAPA's -track compliance alignment versus external audits of other Genzyme network sites This position is responsible for conducting audits of internal and possible external (supplier) quality systems as scheduled, generate audit reports and collect follow-up evaluations on corrective actions which address non-compliance concerns. Requires the ability to coordinate and work with diverse audit teams in evaluation of cGMP quality systems for intermediate and final drug product. Qualifications Basic Qualifications: The candidate will have a Bachelors degree and a minimum of 10 years experience or a Masters Degree and 8 more years experience in a biotech or pharmaceutical regulated industry. Industry experience within manufacturing, deviation/investigation and or other support function areas is a plus. Bachelor's degree in science or engineering or similar experience is required. Must be able to read and interpret complex documentation for compliance with procedures, standards, and regulations. Consistently demonstrate reliable communication skills, and have a great attention to detail. In addition, have sound report writing, verbal and written communication and interpersonal skills. The candidate will have approximately 7 years experience in a QA/Compliance role with demonstrated experience in: utilizing global regulatory regulations, compliance audits, proven/qualified auditing techniques, and developing continuous improvement initiatives for an internal audit program. Preferred Qualifications: The candidate will have a good understanding of global regulations (US, EU, Canada, JP, Australia ) pertaining to auditing and compliance quality programs.

Job Title: Temp, Quality Assurance Associate III Company: Stryker 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/GLP 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 ExperienceBachelor'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 Required5-10%Requisition ID11574BR

Job Title: Research Quality Assurance Associate Company: WestWind Engineering, Inc Location: Santa Monica, CA Description: Research and Development Contact: Register to View The Research Quality Assurance Associate will implement and maintain procedures to ensure the integrity of all research output intended for regulatory submission. The position provides quality guidance to research personnel and ensures that studies are conducted and the data collected in compliance with protocols and appropriate guidelines and work procedures. The position is also responsible for establishing and maintaining the appropriate level of quality systems as required by corporate policies. Position Requirements PhD in Life Sciences preferred. Minimum 2 years in a pharmaceutical development environment with solid knowledge and review experience of in-vivo and in-vitro study protocols and reports. Additional quality assurance experience in a research environment with programs such as document management and equipment qualification is recommended. In-depth understanding of pre-clinical pharmacology studies. Strong oral and written communication skills are required. Strong interpersonal skills and the ability to work in a project team environment are a requirement. Fluency with Word, Excel, and Access databases is recommended.

Job Title: Investigator Compliance Specialist/Sr. Compliance Specialist Company: Genentech, Inc. Location: South San Francisco, CA Description: ABOUT US 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. Our employees cite the chance to make a difference in the lives of patients as the number one reason they enjoy working at Genentech. In hiring new employees, we look for people who are inspired by this mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. 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 facility: Investigator Compliance Specialist/Sr. Compliance Specialist Job ID: Register to View South San Francisco, CA RESPONSIBILITIES: Compliance Specialist/Sr. Compliance Specialist- Investigator The Compliance Specialist/Sr. Compliance Specialist - Investigator will conduct and track individual investigation matters related to enforcement within the healthcare industry. This includes, but is not limited to, compliance with laws enforced by the Food and Drug Administration, Health and Human Services Office of Inspector General, Department of Justice and State Attorney Generals and various agencies. The Investigator works closely with HR,Legal, Security functions, and other members of the Healthcare Compliance Office (HCO) across the spectrum of investigations management, from initial report and assessment through investigation and application of disciplinary action. This position reports to the HCO Director of Auditing, Monitoring, Investigations, and Risk Assessments. - Responsible for understanding the Genentech organization, particularly corporate policies and guidelines, as well as internal organizational dynamics. - Collaborate with HR,Legal, Security functions, and other members of the HCO on investigations. - Ensure appropriate processes are in place to fulfill reporting and oversight of compliance related investigations and incidents. - Develop strategies for the investigation data collection and analysis. - Investigate, or coordinate the investigation, using a variety of evidence, including witness interviews, business records, and other official documents. Prepare and coordinate the preparation of complex case documentation to fully Support findings. - Identify and analyze potential trends and/or signals across compliance related investigations and incidents. - Assist with all other compliance-related duties and special projects as assigned. - Effectively work with outside counsel, when applicable. REQUIRED QUALIFICATIONS, CORE COMPETENCIES, AND EXPERIENCE - BS/BA; advanced degree preferred (e.g., JD, MBA). - Relevant Professional Qualifications a plus (e.g., Certified Fraud Examiner). - 3 years (Compliance Specialist) - 5 years (Sr. Compliance Specialist) experience in the pharma/bio-tech field. - Significant experience in conducting investigations (e.g., law enforcement, regulatory agency, internal investigations, forensic Accounting investigations/consulting). - Significant familiarity with US regulatory requirements related to the development,Manufacturing, and Marketing of bio/pharmaceutical products. - Significant familiarity with industry codes and standards related to industry interactions with Healthcare Professionals (e.g., PhRMA Code). - Ability to travel (approximately 25% of the time). For Compliance Specialist: - High competency in the following areas: priority setting, multi-tasking, planning, process and project oriented, oral and verbal communication, strategic ability, organizational agility, effective decision making, results oriented, team participation, time management, ability to work under pressure and with tight deadlines. - Demonstrated ability to collaborate in a complex and fast paced matrix environment. - Excellent written and oral communication skills, with a proven ability to communicate effectively with senior-level executives - Ability to work independently and as part of a team. - Strong analytical and problem solving skills. For Sr. Compliance Specialist (in addition to those listed above): - Takes initiative and has the ability to work without appreciable direction. - Understands and abides by scope of decision making authority. - Makes decisions with minimal delay as appropriate. - Excellent judgment - sizes up situations accurately in own area of work and looks beyond immediate problems to consider underlying causes and seeks to address these. DIVISION: Legal REQUISITION NUMBER: 1 Register to View Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. To learn more about our current opportunities, please visit: http://careers.gene.com and reference Req. # Register to View . Please use ?Web ? BAJobs? when a source is requested. Genentech is an Equal Opportunity Employer.