Manager of Quality Assurance and Regulatory Affairs Jobs in California
A Manager of Quality Assurance and Regulatory Affairs in the biotechnology industry is responsible for ensuring that all products and services meet required standards and regulations. They ensure compliance with local, national, and international regulatory requirements, oversee quality control processes, and manage audits and inspections. This role also involves creating and implementing policies and procedures to enhance product quality, efficiency, and safety. They also play a crucial role in the product development process, advising on regulatory requirements and ensuring that compliance is maintained throughout the lifecycle of a product.
Skills required for this role include excellent attention to detail, strong organizational and leadership skills, and in-depth knowledge of regulatory standards and quality control methods. In addition, they should have excellent problem-solving skills, the ability to work under pressure, and strong communication skills. They should also have a strong understanding of biotechnology principles and processes. Certifications such as Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Regulatory Affairs Certification (RAC) are often required. Prior roles that can lead to a Manager of Quality Assurance and Regulatory Affairs include Quality Assurance Specialist, Regulatory Affairs Associate, and Quality Control Supervisor.
Compensation: $165,000 - $195,000 per year. You are eligible for a Short-Term Incentive Plan with the target at 20% of your annual earnings; terms and conditions apply. Director of Quality,...
Update maps and documentation for equipment, outlets, and work areas for the main lab, tissue culture room, and radioactive tissue culture room....
US Regulatory Affairs Manager (US-REMOTE)
- Thousand Oaks, CA
- 4 hours ago
- Thousand Oaks, CA
- 4 hours ago
Career Category Regulatory Job Description HOW MIGHT YOU DEFY IMAGINATION? Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How...
Remote WorkWe are hiring in our Diagnostics Regulatory Affairs team here in San Diego, and are looking for a Regulatory Affairs Manager, responsible for on-market regulatory activities associated with US...
Associate Director, Regulatory Affairs
- South San Francisco, CA
- 13 hours ago
- South San Francisco, CA
- 13 hours ago
The Position: Join Maze Therapeutics as an Associate Director, Regulatory Affairs, where you will play a critical role in advancing our clinical-stage programs by providing regulatory expertise...
Associate Director, Regulatory Affairs - CMC (Cell Therapy)
- Santa Monica, CA
- 1 day ago
- Santa Monica, CA
- 1 day ago
Position Summary The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the development and successful performance of the CMC regulatory strategy for the innovative...
Requirements: Undergraduate degree in in Biology, Chemistry, Physical Sciences, or related discipline, or comparable experience. 10 years of experience including management of GxP Quality/Compliance...
Background Requirements: Bachelor's degree in bioengineering/biomedical engineering, biochemistry, chemistry, molecular biology, or related technical science discipline required....
This job requires knowledge of basic principles of chemical engineering, electrochemical measurements, and molecular biology techniques....
Senior Director/ Executive Director, Regulatory Affairs
- San Diego, CA
- 4 days ago
- San Diego, CA
- 4 days ago
Fate Therapeutics is looking for an Executive Director or Senior Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities...
Payroll Title: LAB AST 2 Department: PSYCHOLOGY Hiring Pay Scale $22.03 - $25.90 / Hour Worksite: Campus Appointment Type: Limited Appointment Appointment Percent: 60-100% Union: TX Contract Total...
Crystal Bio Solutions, a member of Crystal Pharmatech, is a leading biologics analytical organization with operations in the San Francisco Bay Area and New Jersey. We specialize in bioanalytical...
About Us Ray Therapeutics is a clinical-stage biopharmaceutical company developing therapies to restore vision in patients affected with retinal degenerations. RayTx utilizes optogenetics to...
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA
- 5 days ago
- South San Francisco, CA
- 5 days ago
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's...
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline...
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in California offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Quality Assurance and Regulatory Affairs position
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Flow Cytometry
- Good Clinical Practice
- Real-Time Polymerase Chain Reaction
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Transfection
- Cloning
- Clinical Laboratory Operations
- Cancer Biology
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Drug Development
- Biology
- Pharmacovigilance
- Stem Cells
- Microbiology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Laboratory Management
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Collections
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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