Director of Quality Assurance and Regulatory Affairs Remote & Hybrid Only Jobs in California
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.
- Cytokinetics, Incorporated
- South San Francisco, CA
- 4 days ago
- South San Francisco, CA
- 4 days ago
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new...
HybridTechnical Lab Manager Application Deadline: 29 May 2026 Department: Network Planning and Operational Structure Employment Type: Full Time Location: Emeryville, CA Reporting To: Pilot Facility...
HybridSenior Director, Regulatory Affairs CMC
- Mirum Pharmaceuticals Inc
- Foster City, CA
- 60+ days ago
- Foster City, CA
- 60+ 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...
HybridDirector, Regulatory Affairs - Global Filing Lead
- Revolution Medicines, Inc.
- Redwood City, CA
- 90+ days ago
- Redwood City, CA
- 90+ days ago
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors...
HybridDirector, Regulatory Affairs (US Filing Lead)
- Revolution Medicines, Inc.
- Redwood City, CA
- 90+ days ago
- Redwood City, CA
- 90+ days ago
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors...
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in California 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
- Continuous Improvement
- Quality Systems
- Quality Management
- Change Control
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Molecular Biology
- ICH Guidelines
- Institutional Review Board
- ICH GCP
- Drug Development
- Clinical Laboratory Operations
- Medical Affairs
- Lab Safety
- Tissue Culture
- Gene Therapy
- Pharmacovigilance
- Biochemistry
- Microbiology
- Biology
- Immunology
- Good Laboratory Practice
- Clinical Trials
- Autoclave
- Lab Experience
- Clinical Research
- Biotechnology
- Laboratory Management
- Equipment Calibration
- Neuroscience
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Strategy Development
- Engineering
- Auditing
- Investigation
- Quality Assurance
- Documentation
- Mentoring
- Interpersonal Skills
- Implementation
- Verbal Communication
- Reporting
- Inventory Management
- Policy Development
- Collaboration
- Education Experience
- Bachelor's Degree
- Regulations
- Research Skills
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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