Director of Quality Assurance and Regulatory Affairs Jobs
A Director of Quality Assurance and Regulatory Affairs in the biotechnology industry is essentially responsible for developing and implementing systems that ensure products meet quality standards and regulatory requirements. This includes conducting internal audits, leading investigations into quality issues, liaising with regulatory bodies, and overseeing the submission of regulatory documents. They are also responsible for ensuring compliance with regulatory requirements and standards such as ISO, FDA, and EMEA. They play a crucial role in maintaining the company's reputation and ensuring customer satisfaction by ensuring that products are safe, reliable, and meet both customer and regulatory requirements.
Key skills for this role include strong analytical and problem-solving skills, excellent communication skills, and a strong knowledge of the biotechnology industry and its associated regulations. They should also have strong leadership skills, as they will often be leading teams and coordinating with other departments. Important certifications may include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC), or Certified Quality Manager (CQM). Prior to becoming a Director of Quality Assurance and Regulatory Affairs, an individual may have roles such as Quality Assurance Manager, Regulatory Affairs Specialist, or Senior Quality Engineer within the industry.
- Food Safety Net Services
- Logan, UT
- 4 days ago
- Food Safety Net Services
- Logan, UT
- 4 days ago
Certified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. The Certified Group of companies includes Food Safety Net...
Regulatory Affairs Manager - Electrophysiology (on-site)
- Plymouth, MN
- 15 days ago
- Plymouth, MN
- 15 days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Regulatory Affairs Manager Heart Failure (on-site)
- Pleasanton, CA
- 45+ days ago
- Pleasanton, CA
- 45+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Comprehensive knowledge of relevant FDA regulations, ICH guidelines, and global regulatory frameworks....
Job Summary: The Quality Control Lab Manager will support the establishment and operation of our cGMP QC lab including but not limited to: Equipment receipt and installation, lab operations and...
guidelines and regulations Excellent organizational and communication skills, both written and verbal Ability to work independently as well as part of a team environment Positive attitude, energetic...
California, US residents click here (. **The job details are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit...
Director Regulatory Affairs Alliance and Commercialization - Remote Opportunity
- Deerfield, IL
- 17 hours ago
- Deerfield, IL
- 17 hours ago
Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company...
Lab Manager Ford Motor Company - 4.1 Palo Alto, CA Job Details Estimated: $79.8K - $108K a year 23 hours ago Benefits Paid parental leave Paid holidays Visa sponsorship Health insurance Dental...
Lab Manager Employer Proclinical Staffing Location New Jersey, Basking Ridge, USA Salary USD60 - USD70 per hour Start date 11 Jun 2025 Closing date 25 Jun 2025 categories Apply now Job Details...
Remote WorkCompany Name: Datascope Corp.Job Location: 45 Barbour Pond Drive, Wayne, NJ 07470. Employer will allow remote/telecommuting throughout the U.S.Job title: Senior Director Quality & Regulatory...
Lab Manager Aviagen Group Occupation: Ophthalmic Laboratory Technicians Location: Walpole, NH - 03608 Positions available: 1 Job #: JR100471 Source: Aviagen Group Posted: 6/4/2025 Web Site:...
Current studies employ molecular biology (PCRs, cloning), cell biology/biochemistry (Cell culture, protein work), animal models (mouse models; tumor xenografts, genotyping) combined with unbiased metabolomics...
Supervisory Clinical Laboratory Scientist (Lab Manager)
- Fayetteville, NC
- 1 day ago
- Fayetteville, NC
- 1 day ago
Summary The Supervisor serves as a Supervisory Clinical Laboratory Scientist for the Pathology and Laboratory Medicine Service (P&LMS) at the Fayetteville VA Medical Center and/or Satellite...
- New Port Richey, FL
- 1 day ago
- New Port Richey, FL
- 1 day ago
Company Description ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry-leading practices....
Director of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities
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Required or preferred licenses and certifications for Director of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
Director of Quality Assurance and Regulatory Affairss offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Quality Assurance and Regulatory Affairs position
- Mentoring
- Quality Systems
- Implementation
- Quality Management
- Change Control
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Institutional Review Board
- ICH GCP
- Assay Development
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Next-Generation Sequencing
- Polymerase Chain Reaction
- Drug Development
- Western Blot
- Biochemistry
- Biology
- Pharmacovigilance
- Immunology
- Medical Writing
- Microbiology
- Scientific Writing
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- General Repair
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Collaboration
- Documentation
- Quality Assurance
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Regulations
- Inventory Management
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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