Manager of Quality Assurance and Regulatory Affairs Jobs in Pleasanton, CA
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.
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...
Associate Director, Regulatory Affairs
- Redwood City, CA (24 miles from Pleasanton, CA)
- 6 days ago
- Redwood City, CA (24 miles from Pleasanton, CA)
- 6 days ago
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...
Senior Director, Regulatory Affairs Global Regulatory Leader
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 12 days ago
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 12 days ago
industry, and trade groups as appropriate Follows budget allocations All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor's degree in life sciences (pharmacy, biology...
Executive Director, Regulatory Affairs
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 12 days ago
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 12 days ago
requirements Develops and follows budget allocations All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Doctorate or Masters degree in life sciences (pharmacy, biology...
Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA
- 90+ days ago
- Pleasanton, CA
- 90+ days ago
Preferred Qualifications Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
Senior Manager, Regulatory Affairs
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 30+ days ago
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 30+ days ago
Overview of Role: Reporting to Head of Regulatory Affairs, the Senior Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. These assigned projects...
Associate Director, Regulatory Affairs Advertising and Promotion
- Foster City, CA (23 miles from Pleasanton, CA)
- 45+ days ago
- Foster City, CA (23 miles from Pleasanton, CA)
- 45+ days ago
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
Associate Director, Regulatory Affairs
- Foster City, CA (23 miles from Pleasanton, CA)
- 45+ days ago
- Foster City, CA (23 miles from Pleasanton, CA)
- 45+ days ago
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important...
- Stanford, CA (23 miles from Pleasanton, CA)
- 60+ days ago
- Stanford, CA (23 miles from Pleasanton, CA)
- 60+ days ago
At least one year of research experience in molecular biology and cell culture, and proficiency in animal necropsy, tissue dissociation, flow cytometry, immunocytochemistry, tissue cryo-sectioning and...
Associate Director, Regulatory Affairs CMC
- Foster City, CA (23 miles from Pleasanton, CA)
- 60+ days ago
- Foster City, CA (23 miles from Pleasanton, CA)
- 60+ days ago
For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, were creating a healthier world for all people. For more than 35 years,...
Manager, Regulatory Affairs- Body Contouring
- Pleasanton, CA
- 60+ days ago
- Pleasanton, CA
- 60+ days ago
Qualifications BS or BA in engineering, biology or other health sciences; plus five-year experience in regulatory affairs....
Director / Senior Director, Regulatory Affairs
- Redwood City, CA (24 miles from Pleasanton, CA)
- 90+ days ago
- Redwood City, CA (24 miles from Pleasanton, CA)
- 90+ days ago
About Soleno Therapeutics Inc Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare...
- Stanford, CA (23 miles from Pleasanton, CA)
- 90+ days ago
- Stanford, CA (23 miles from Pleasanton, CA)
- 90+ days ago
Lab Manager- On-Site The School of Humanities and Sciences (H&S) is the foundation of a liberal arts education at Stanford. The school encompasses 23 departments and 25 interdisciplinary programs....
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Pleasanton, CA 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
- Cloning
- Clinical Laboratory Operations
- Cancer Biology
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Drug Development
- Biology
- Medical Writing
- 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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