Director of Quality Assurance and Regulatory Affairs Jobs in San Carlos, 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/Sr. Director, Regulatory Affairs
- San Francisco, CA (21 miles from San Carlos, CA)
- 2 days ago
- San Francisco, CA (21 miles from San Carlos, CA)
- 2 days ago
About QED Therapeutics & BridgeBio Pharma QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly...
- Alameda, CA (19 miles from San Carlos, CA)
- 3 days ago
- Alameda, CA (19 miles from San Carlos, CA)
- 3 days ago
Preferred Qualifications Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
Associate Director, Regulatory Affairs
- South San Francisco, CA (14 miles from San Carlos, CA)
- 6 days ago
- South San Francisco, CA (14 miles from San Carlos, CA)
- 6 days 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...
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA (14 miles from San Carlos, CA)
- 11 days ago
- South San Francisco, CA (14 miles from San Carlos, CA)
- 11 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...
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Associate Director, Regulatory Affairs
- Redwood City, CA (2 miles from San Carlos, CA)
- 12 days ago
- Redwood City, CA (2 miles from San Carlos, CA)
- 12 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 (5 miles from San Carlos, CA)
- 18 days ago
- Menlo Park, CA (5 miles from San Carlos, CA)
- 18 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...
Executive Director, Regulatory Affairs
- Menlo Park, CA (5 miles from San Carlos, CA)
- 18 days ago
- Menlo Park, CA (5 miles from San Carlos, CA)
- 18 days ago
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, Regulatory Affairs
- San Francisco, CA (21 miles from San Carlos, CA)
- 23 days ago
- San Francisco, CA (21 miles from San Carlos, CA)
- 23 days ago
About QED Therapeutics & BridgeBio Pharma QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly...
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (19 miles from San Carlos, CA)
- 27 days ago
- Alameda, CA (19 miles from San Carlos, CA)
- 27 days ago
Preferred Qualifications Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields; Masters degree...
Associate Director, Quality Assurance and Compliance
- San Carlos, CA
- 30+ days ago
- San Carlos, 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 (14 miles from San Carlos, CA)
- 30+ days ago
- South San Francisco, CA (14 miles from San Carlos, 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...
Director, Regulatory Affairs CMC
- San Francisco, CA (21 miles from San Carlos, CA)
- 30+ days ago
- San Francisco, CA (21 miles from San Carlos, CA)
- 30+ days ago
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...
Senior Director Regulatory Affairs
- San Francisco, CA (21 miles from San Carlos, CA)
- 30+ days ago
- San Francisco, CA (21 miles from San Carlos, CA)
- 30+ days ago
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...
- San Francisco, CA (21 miles from San Carlos, CA)
- 30+ days ago
- San Francisco, CA (21 miles from San Carlos, 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....
Senior Manager, Regulatory Affairs
- Menlo Park, CA (5 miles from San Carlos, CA)
- 30+ days ago
- Menlo Park, CA (5 miles from San Carlos, CA)
- 30+ days ago
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...
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in San Carlos, 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
- Affirmative Action
- Quality Systems
- Implementation
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Good Clinical Practice
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Bioinformatics
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Clinical Trials
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Standard Operating Procedures
- Diagnostic
- Product Development
- Engineering
- Strategy Development
- 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
- Computer Skills
- Leadership
- Communication Skills
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