Director of Quality Assurance and Regulatory Affairs Jobs in San Diego, 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.
Education Bachelor's degree in a scientific discipline: Engineering, Biology, etc. or equivalent. Advanced degree (Master's degree or higher) preferred....
development organizations Ensure Regulatory resources are available to support inspections conducted by global regulators Qualifications: M.S. degree in a technical discipline (e.g., engineering, biology...
Associate Director, Regulatory Affairs CMC - San Diego, CA
- San Diego, CA
- 19 days ago
- San Diego, CA
- 19 days ago
Plan, prepare, author, and/or review CMC-focused content for health authority submissions (e.g., scientific advice briefing packages, CTA, MAA) to health authorities to support clinical trials, registration...
Manager, Regulatory Affairs (IVD On-Market/Sustaining)
- San Diego, CA
- 28 days ago
- San Diego, CA
- 28 days ago
We are hiring in our Diagnostics Regulatory Affairs team based out of our San Diego or Marlborough campus, and are looking for a Regulatory Affairs Manager, responsible for on-market regulatory...
Perform regulatory checks and develop checklists to confirm compliant clinical trial activation, and provide ongoing guidance to team members to streamline clinical trial activation processes in the...
Senior Director Regulatory Affairs (Dispensing and Pharmacy Automation Platforms)
- San Diego, CA
- 30+ days ago
- San Diego, CA
- 30+ days ago
development organizations Ensure Regulatory resources are available to support inspections conducted by global regulators Qualifications: M.S. degree in a technical discipline (e.g., engineering, biology...
Requirements Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred....
We are hiring in our Diagnostics Regulatory Affairs team here in San Diego, and are looking for a Regulatory Affairs Manager, responsible for on-market regulatory activities associated with US...
Associate Director Regulatory Affairs (hybrid)
- San Diego, CA
- 60+ days ago
- San Diego, CA
- 60+ days ago
Education Bachelors degree in a scientific discipline: Engineering, Biology, etc. or equivalent. Advanced degree (Masters degree or higher) preferred....
The Position This position is responsible for supporting multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements and guidelines, and develop and execute...
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Director of Quality Assurance and Regulatory Affairss in San Diego, 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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