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/Senior Director, Regulatory Affairs (Clinical & CMC)
- San Francisco, CA
- 7 hours ago
- San Francisco, CA
- 7 hours ago
Director/Senior Director, Regulatory Affairs (Clinical & CMC) August 2025 Department: Regulatory Position Summary: The Director/Senior Director, Regulatory Affairs will lead and execute global...
Who we are The problem: Every minute matters in fire response. As climate change amplifies the intensity of wildfireswith longer fire seasons, dryer fuels, and faster windsnew ignitions spread...
Associate Director, Quality Assurance
- South San Francisco, CA (8 miles from San Francisco, CA)
- 3 days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 3 days ago
As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility...
: Bachelor's degree required; advanced degree in life sciences preferred. 7+ years or equivalent relevant experience in regulatory affairs in the biopharmaceutical industry Strong understanding of ICH...
Exec Director, Regulatory Affairs-Combination Products & Devices
- Foster City, CA (17 miles from San Francisco, CA)
- 11 days ago
- Foster City, CA (17 miles from San Francisco, CA)
- 11 days ago
In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of small molecules and biologics....
Associate Director/ Director, Regulatory Affairs
- Foster City, CA (17 miles from San Francisco, CA)
- 12 days ago
- Foster City, CA (17 miles from San Francisco, CA)
- 12 days ago
Associate Director/ Director, Regulatory Affairs About the Company: Dren Bio (the "Company") is a privately held, clinical stage biopharmaceutical company focused on developing therapeutic...
Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and...
Regulatory Affairs Manager Canada & Latin America 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 Bachelors degree in Biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology math, engineering, or medical fields....
- Redwood City, CA (23 miles from San Francisco, CA)
- 19 days ago
- Redwood City, CA (23 miles from San Francisco, CA)
- 19 days ago
In-depth knowledge and application of GMP and ICH Guidelines....
Manager, Regulatory Affairs-Document Coordinator
- San Francisco, CA
- 25 days ago
- San Francisco, CA
- 25 days ago
Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and...
Commercial Regulatory Affairs Director (Advertising and Promotion)
- Alameda, CA (7 miles from San Francisco, CA)
- 26 days ago
- Alameda, CA (7 miles from San Francisco, CA)
- 26 days ago
SUMMARY/JOB PURPOSE: Responsible for primary regulatory review of promotional materials and scientific exchange communications. This role demonstrates proficiency in understanding and interpreting...
Associate Director, Regulatory Affairs
- South San Francisco, CA (8 miles from San Francisco, CA)
- 27 days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 27 days ago
: Bachelor's degree required; advanced degree in life sciences preferred. 7+ years or equivalent relevant experience in regulatory affairs in the biopharmaceutical industry Strong understanding of ICH...
Senior Director, Regulatory Affairs
- South San Francisco, CA (8 miles from San Francisco, CA)
- 27 days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 27 days ago
As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility...
Regulatory Affairs Manager - APAC - 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 Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
About the Role >>> Director, Regulatory Labeling As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you will lead the development of...
Demographic Data for San Francisco, CA
Moving to San Francisco, CA? Find some basic demographic data about San Francisco, CA below.
Director 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 Director of Quality Assurance and Regulatory Affairs Jobs in San Francisco, CA
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 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
- Quality Systems
- Implementation
- Change Control
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- ICH GCP
- Assay Development
- Institutional Review Board
- Animal Models
- Spectrophotometer
- Cancer Research
- Gene Therapy
- Lab Safety
- Molecular Biology
- ICH Guidelines
- Medical Affairs
- Next-Generation Sequencing
- Clinical Laboratory Operations
- Water Testing
- Biology
- Scientific Research
- Microbiology
- Drug Development
- Pharmacovigilance
- Fermentation
- Immunology
- Medical Writing
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Collections
- Strategy Development
- Quality Control
- Auditing
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Inventory Management
- Interpersonal Skills
- Bachelor's Degree
- Policy Development
- Project Management
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Director 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 »