Director of Quality Assurance and Regulatory Affairs Jobs in San Francisco, CA
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.
Director, Regulatory Affairs CMC
- Foster City, CA (17 miles from San Francisco, CA)
- 4 days ago
- Foster City, CA (17 miles from San Francisco, CA)
- 4 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)
- 7 days ago
- Alameda, CA (7 miles from San Francisco, CA)
- 7 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....
- San Carlos, CA (21 miles from San Francisco, CA)
- 14 days ago
- San Carlos, CA (21 miles from San Francisco, CA)
- 14 days ago
Manager, Quality Assurance in San Carlos, California Overview Manager, Quality Assurance W2 Contract-to-Hire Pay Rate: $60 - $65 per hour Location: San Carlos, CA - Hybrid Role Job Summary: We are...
- South San Francisco, CA (8 miles from San Francisco, CA)
- 18 days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 18 days ago
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)
- 18 days ago
- Brisbane, CA (6 miles from San Francisco, CA)
- 18 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)
- 22 days ago
- Pacheco, CA (19 miles from San Francisco, CA)
- 22 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...
Associate Manager/Manager, Quality Assurance
- Burlingame, CA (14 miles from San Francisco, CA)
- 23 days ago
- Burlingame, CA (14 miles from San Francisco, CA)
- 23 days ago
Compliance: Ensure compliance with current Good Manufacturing Practices (cGMPs), Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), FDA regulations, ICH guidelines, 21 CFR Part 11, and...
- South San Francisco, CA (8 miles from San Francisco, CA)
- 26 days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 26 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)....
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA (7 miles from San Francisco, CA)
- 27 days ago
- Alameda, CA (7 miles from San Francisco, CA)
- 27 days ago
Preferred Qualifications Bachelors degree in Biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology math, engineering, or medical fields....
Core Lab Manager University of California San Francisco
- San Francisco, CA
- 30+ days ago
- San Francisco, CA
- 30+ 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)
- 30+ days ago
- Foster City, CA (17 miles from San Francisco, CA)
- 30+ 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)
- 30+ days ago
- Alameda, CA (7 miles from San Francisco, CA)
- 30+ days ago
Reviews and approves clinical development communications and materials in support of Exelixis clinical trials, including site training slides and newsletters....
- South San Francisco, CA (8 miles from San Francisco, CA)
- 45+ days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 45+ days ago
Who You Are: Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related life sciences Required Experience: 5+ years of regulatory experience in IVD, companion diagnostics...
Demographic Data for San Francisco, CA
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Highest Education Level
Director 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 Director of Quality Assurance and Regulatory Affairs position
- Mentoring
- Electrical Engineering
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Drug Development
- Biology
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Research and Development
- Process Development
- Diagnostic
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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