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.
- Cytokinetics, Incorporated
- South San Francisco, CA (14 miles from San Carlos, CA)
- 4 days ago
- South San Francisco, CA (14 miles from San Carlos, 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...
HybridSr Manager, Regulatory Affairs CMC
- Gilead Sciences
- Foster City, CA (4 miles from San Carlos, CA)
- 15 days ago
- Foster City, CA (4 miles from San Carlos, CA)
- 15 days ago
Examples include safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations, and original INDs/CTAs and NDAs/MAAs for assigned territories...
In PersonDirector, Regulatory Affairs - Oncology Early Development
- AbbVie, Inc
- South San Francisco, CA (14 miles from San Carlos, CA)
- 20 days ago
- South San Francisco, CA (14 miles from San Carlos, CA)
- 20 days ago
trials in 19 different types of cancer....
In PersonTechnical Lab Manager - Robotics R&D, Frontier AI & Robotics
- Amazon.com, Inc.
- San Francisco, CA (21 miles from San Carlos, CA)
- 28 days ago
- San Francisco, CA (21 miles from San Carlos, CA)
- 28 days ago
Description Join our Frontier AI & Robotics team to lead the hardware integration of next-generation robotic systems that will transform how robots perceive and interact with the world. You'll...
In Person- Nurix Therapeutics, Inc.
- Brisbane, CA (15 miles from San Carlos, CA)
- 29 days ago
- Brisbane, CA (15 miles from San Carlos, CA)
- 29 days ago
guidelines and regulations Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA Proven track record...
In PersonSenior Manager Regulatory Affairs (contract)
- Alumis Inc.
- 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
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients...
In Person- BioMADE
- Oakland, CA (19 miles from San Carlos, CA)
- 30+ days ago
- Oakland, CA (19 miles from San Carlos, CA)
- 30+ days ago
Technical 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 Regulatory Affairs Director - Oncology Cell & Gene Therapy
- AstraZeneca
- South San Francisco, CA (14 miles from San Carlos, CA)
- 45+ days ago
- South San Francisco, CA (14 miles from San Carlos, CA)
- 45+ days ago
Job Description The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation of the global regulatory strategy for CGT products of high...
In PersonSenior Director, Regulatory Affairs CMC
- Mirum Pharmaceuticals Inc
- Foster City, CA (4 miles from San Carlos, CA)
- 60+ days ago
- Foster City, CA (4 miles from San Carlos, 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 (2 miles from San Carlos, CA)
- 90+ days ago
- Redwood City, CA (2 miles from San Carlos, 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 (2 miles from San Carlos, CA)
- 90+ days ago
- Redwood City, CA (2 miles from San Carlos, 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...
HybridSenior Manager, Regulatory Affairs
- Summit Therapeutics Sub, Inc.
- Palo Alto, CA (7 miles from San Carlos, CA)
- 90+ days ago
- Palo Alto, CA (7 miles from San Carlos, CA)
- 90+ days ago
Role and Responsibilities: Provide ownership of molecule and study-level regulatory activities, including global clinical trial applications (CTAs) and IND submissions, review and approval of investigator...
In PersonDemographic Data for San Carlos, CA
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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
- 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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