Manager of Quality Assurance and Regulatory Affairs Jobs in San Francisco, 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.
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA (7 miles from San Francisco, CA)
- 30+ days ago
- Alameda, CA (7 miles from San Francisco, CA)
- 30+ days ago
Preferred Qualifications Bachelors degree in Biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology math, engineering, or medical fields....
Clinical Research Regulatory Affairs Manager
- South San Francisco, CA (8 miles from San Francisco, CA)
- 1 day ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 1 day ago
Who You Are: Required Education: Bachelors degree in pharmacy, biology, chemistry, pharmacology, or related life sciences Required Experience: 5+ years of regulatory experience in IVD, companion diagnostics...
Director, Regulatory Affairs Medical Writer
- South San Francisco, CA (8 miles from San Francisco, CA)
- 2 days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 2 days ago
Sutro Biopharma, Inc. is looking for a Director, Regulatory Affairs Medical Writer who will provide leadership in development and execution of document deliverables intended to support clinical trial...
Director, Regulatory Affairs CMC
- Foster City, CA (17 miles from San Francisco, CA)
- 17 days ago
- Foster City, CA (17 miles from San Francisco, CA)
- 17 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...
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (7 miles from San Francisco, CA)
- 19 days ago
- Alameda, CA (7 miles from San Francisco, CA)
- 19 days ago
Preferred Qualifications Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields; Masters degree...
Adhere to a prescribed schedule for cleaning tissue culture rooms, including hoods, incubators, and water baths. Handle biohazard and chemical waste according to OSHA standards....
Senior Director, Regulatory Affairs (CMC)
- Brisbane, CA (6 miles from San Francisco, CA)
- 30+ days ago
- Brisbane, CA (6 miles from San Francisco, CA)
- 30+ days ago
Position Summary: Ultragenyx is seeking a highly motivated Senior Director, Regulatory Affairs CMC, who is a team builder and enjoys a fast-paced, dynamic work environment. In this position, the...
Senior Regulatory Affairs Manager
- Pacheco, CA (19 miles from San Francisco, CA)
- 30+ days ago
- Pacheco, CA (19 miles from San Francisco, CA)
- 30+ days ago
Senior Regulatory Affairs Manager Pacheco, California, United States Our Company Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry...
- South San Francisco, CA (8 miles from San Francisco, CA)
- 30+ days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 30+ days ago
Supports the conduct of clinical trials and approval of marketing applications while holding responsibility for the maintenance of these applications (INDs, CTAs, DMFs, BLAs, MAAs)....
Core Lab Manager University of California San Francisco
- San Francisco, CA
- 45+ days ago
- San Francisco, CA
- 45+ days ago
The Core Lab Manager provides daily operational management support for the Clinical Laboratory in assigned areas. Manages productivity, technical performance of specimen processing and laboratory...
The Core Lab Manager provides daily operational management support for the Clinical Laboratory in assigned areas. Manages productivity, technical performance of specimen processing and laboratory...
Associate Director, Regulatory Affairs - Global Labeling
- Foster City, CA (17 miles from San Francisco, CA)
- 45+ days ago
- Foster City, CA (17 miles from San Francisco, CA)
- 45+ days ago
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop...
Commercial Regulatory Affairs Director
- Alameda, CA (7 miles from San Francisco, CA)
- 45+ days ago
- Alameda, CA (7 miles from San Francisco, CA)
- 45+ days ago
Reviews and approves clinical development communications and materials in support of Exelixis clinical trials, including site training slides and newsletters....
Associate Director, Regulatory Affairs
- Foster City, CA (17 miles from San Francisco, CA)
- 90+ days ago
- Foster City, CA (17 miles from San Francisco, CA)
- 90+ days ago
Support the Clinical Operation Team with Clinical Trial Applications. Leads the preparation and the critical review of submission documents to ensure compliance with regulatory requirements....
Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (7 miles from San Francisco, CA)
- 90+ days ago
- Alameda, CA (7 miles from San Francisco, CA)
- 90+ days ago
Preferred Qualifications Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
Demographic Data for San Francisco, CA
Moving to San Francisco, CA? Find some basic demographic data about San Francisco, CA below.
Manager of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job titles
Salary for Manager of Quality Assurance and Regulatory Affairs Jobs in San Francisco, CA
Required or preferred licenses and certifications for Manager of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in San Francisco, 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
- Continuous Improvement
- Affirmative Action
- Quality Systems
- Implementation
- Quality Management
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- TrackWise
- Institutional Review Board
- ICH GCP
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Neurobiology
- Clinical Laboratory Operations
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Experimental Design
- Biotechnology
- Scientific Writing
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Manager of Quality Assurance and Regulatory Affairs Related Career Advice Articles
4 Biotech Opportunities & Career Paths With High Growth Potential
Biotechnology is an emerging segment of the employment market with opportunities spanning healthcare, biopharmaceuticals, agriculture, industry, and academia. If you have a thirst for innovation, this career path might be right for you!
Read article »