Director of Quality Assurance and Regulatory Affairs Jobs in Menlo Park, 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 (18 miles from Menlo Park, CA)
- 14 hours ago
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 14 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...
- Pleasanton, CA (22 miles from Menlo Park, CA)
- 5 days ago
- Pleasanton, CA (22 miles from Menlo Park, CA)
- 5 days ago
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...
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 5 days ago
- South San Francisco, CA (18 miles from Menlo Park, 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 (3 miles from Menlo Park, CA)
- 6 days ago
- Redwood City, CA (3 miles from Menlo Park, 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
- 12 days ago
- Menlo Park, 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...
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...
Associate Director, Quality Assurance and Compliance
- San Carlos, CA (5 miles from Menlo Park, CA)
- 30+ days ago
- San Carlos, CA (5 miles from Menlo Park, 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 (18 miles from Menlo Park, CA)
- 30+ days ago
- South San Francisco, CA (18 miles from Menlo Park, 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...
Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA (22 miles from Menlo Park, CA)
- 90+ days ago
- Pleasanton, CA (22 miles from Menlo Park, 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 Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (22 miles from Menlo Park, CA)
- 22 days ago
- Alameda, CA (22 miles from Menlo Park, 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...
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 (8 miles from Menlo Park, CA)
- 45+ days ago
- Foster City, CA (8 miles from Menlo Park, 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 (8 miles from Menlo Park, CA)
- 45+ days ago
- Foster City, CA (8 miles from Menlo Park, 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...
Executive Director, Regulatory Affairs CMC
- Alameda, CA (22 miles from Menlo Park, CA)
- 45+ days ago
- Alameda, CA (22 miles from Menlo Park, CA)
- 45+ days ago
SUMMARY/JOB PURPOSE: This role provides CMC Regulatory expertise and leadership for commercial and development projects. This role leads all regulatory activities related to chemistry,...
- Stanford, CA (2 miles from Menlo Park, CA)
- 60+ days ago
- Stanford, CA (2 miles from Menlo Park, 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...
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Menlo Park, 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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