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.
Associate Director, Regulatory Affairs
- South San Francisco, CA (8 miles from San Francisco, CA)
- 19 hours ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 19 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...
Director of Regulatory Affairs
- Berkeley, CA (10 miles from San Francisco, CA)
- 5 days ago
- Berkeley, CA (10 miles from San Francisco, CA)
- 5 days ago
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 (8 miles from San Francisco, CA)
- 5 days ago
- South San Francisco, CA (8 miles from 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...
Associate Director, Regulatory Affairs
- Redwood City, CA (23 miles from San Francisco, CA)
- 6 days ago
- Redwood City, CA (23 miles from San Francisco, 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...
Manager/Sr Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) - Remote
- San Francisco, CA
- 13 days ago
- San Francisco, CA
- 13 days ago
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in...
Remote WorkAbout QED Therapeutics & BridgeBio Pharma QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly...
Associate Director, Quality Assurance and Compliance
- San Carlos, CA (21 miles from San Francisco, CA)
- 30+ days ago
- San Carlos, CA (21 miles from San Francisco, CA)
- 30+ days ago
., Biology, Chemistry, Engineering, or related field). 10+ years of experience in Quality Assurance, Compliance, or Regulatory Affairs in the biopharmaceutical or vaccine industry....
Director, Regulatory Affairs-CMC
- 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
The Position: Maze Therapeutics is seeking a Director, Regulatory Affairs-CMC to be a key driver of CMC regulatory strategy for our clinical-stage small molecule programs. In this highly...
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (7 miles from San Francisco, CA)
- 22 days ago
- Alameda, CA (7 miles from San Francisco, CA)
- 22 days ago
Preferred Qualifications Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields; Masters degree...
About the Role >>> Director, Regulatory Affairs CMC As the Director, Regulatory Affairs CMC, reporting to the Senior Director, Regulatory Affairs CMC, you will be responsible for developing and...
Title: Senior Director Regulatory Affairs SUMMARY: A leading biopharmaceutical company is seeking a Sr. Director of Regulatory Affairs. This role involves developing and implementing global...
Lab Manager (9602C) 76850 University of California, Berkeley
- Berkeley, CA (10 miles from San Francisco, CA)
- 30+ days ago
- Berkeley, CA (10 miles from San Francisco, CA)
- 30+ days ago
Required Qualifications Experience with mouse handling, molecular biology and behavior techniques, and knowledge of lab safety procedures. Leadership skills and being able to work independently....
Required Qualifications Experience with mouse handling, molecular biology and behavior techniques, and knowledge of lab safety procedures. Leadership skills and being able to work independently....
Jones Lab - Junior/Assistant/Associate/Full Specialist (Lab Manager)
- San Francisco, CA
- 30+ days ago
- San Francisco, CA
- 30+ days ago
tissue culture or animal models Skills in tissue dissections and molecular biology techniques, including working with DNA, protein (immunoprecipitation and Western blotting), RNA extraction, qPCR and...
- San Francisco, CA
- 30+ days ago
- San Francisco, CA
- 30+ days ago
tissue culture or animal models Skills in tissue dissections and molecular biology techniques, including working with DNA, protein (immunoprecipitation and Western blotting), RNA extraction, qPCR and...
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
- 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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