Director of Quality Assurance and Regulatory Affairs 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.
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
- South San Francisco, CA
- 8 hours ago
- South San Francisco, CA
- 8 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...
Associate Director, Regulatory Affairs - CMC (Cell Therapy)
- Santa Monica, CA
- 23 hours ago
- Santa Monica, CA
- 23 hours ago
Position Summary The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the development and successful performance of the CMC regulatory strategy for the innovative...
Requirements: Undergraduate degree in in Biology, Chemistry, Physical Sciences, or related discipline, or comparable experience. 10 years of experience including management of GxP Quality/Compliance...
Background Requirements: Bachelor's degree in bioengineering/biomedical engineering, biochemistry, chemistry, molecular biology, or related technical science discipline required....
This job requires knowledge of basic principles of chemical engineering, electrochemical measurements, and molecular biology techniques....
Senior Director/ Executive Director, Regulatory Affairs
- San Diego, CA
- 4 days ago
- San Diego, CA
- 4 days ago
Fate Therapeutics is looking for an Executive Director or Senior Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities...
Payroll Title: LAB AST 2 Department: PSYCHOLOGY Hiring Pay Scale $22.03 - $25.90 / Hour Worksite: Campus Appointment Type: Limited Appointment Appointment Percent: 60-100% Union: TX Contract Total...
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...
About Us Ray Therapeutics is a clinical-stage biopharmaceutical company developing therapies to restore vision in patients affected with retinal degenerations. RayTx utilizes optogenetics to...
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA
- 5 days ago
- South San Francisco, 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...
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...
Education Bachelors degree in a scientific discipline: Engineering, Biology, etc. or equivalent. Advanced degree (Masters degree or higher) preferred....
Directs and controls the day-to-day operations for their specific area of responsibility, which includes all personnel activities, technical oversight, general work flow and budget. Ensures...
This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology....
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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
- 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
- Transfection
- 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
- 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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