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.
Associate Director, Quality Assurance and Compliance
- San Carlos, CA
- 1 day ago
- San Carlos, CA
- 1 day ago
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases,...
Lab Manager (9602C) 76850 University of California, Berkeley
- Berkeley, CA
- 1 day ago
- Berkeley, CA
- 1 day 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....
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....
Clinical Laboratory Manager OR CLS Manager OR Lab Manager. Job in Bodfish Gr8Jobs
- Bodfish, CA
- 4 days ago
- Bodfish, CA
- 4 days ago
Lab Manager - CLS (ASCP) - Day Shift Location: Bodfish, CA Compensation: $141,000 - $200,000 annually (Based on experience) Schedule: Full-time, Day Shift About Us: Join our dedicated team in...
Senior Manager, Regulatory Affairs US Advertising and Promotion - Neuroscience
- East Irvine, CA
- 4 days ago
- East Irvine, CA
- 4 days ago
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive...
Director of Quality Assurance - Cell and Gene Therapy Operations
- Duarte, CA
- 4 days ago
- Duarte, CA
- 4 days ago
Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and...
Job Title: Associate Director, Regulatory Affairs Location: San Diego, CA / Hybrid / Remote Position type: FLSA: Full time Exempt Department: Finance ID: Regulatory 8300-Q224-9 Strive to Bring a...
Director, Regulatory Affairs-CMC
- South San Francisco, CA
- 5 days ago
- South San Francisco, CA
- 5 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...
The Position Join Maze Therapeutics as a Director, Regulatory Affairs, where you will play a critical leadership role in advancing our clinical-stage programs, providing regulatory expertise to...
About the Company Marea Therapeutics is a clinical-stage biotechnology company based in San Francisco with a growing pipeline of first-in-class therapies to address genetically validated...
Job description Leanteq is best-in-class in a very niche part of the semiconductor industry and is looking for quality-oriented people who enjoy working in a great culture to join our team. Our...
Title: Regulatory Affairs Senior Manager Summary: Our client is seeking an experienced Senior Manager of Regulatory Affairs to lead the preparation and submission of global regulatory filings,...
Sr Manager, Regulatory Affairs (Remote) - Shockwave
- Santa Clara, CA
- 8 days ago
- Santa Clara, CA
- 8 days ago
J&J Family of Companies Sr Manager, Regulatory Affairs (Remote) - Shockwave in Santa Clara , California At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation...
Remote WorkOverview 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...
Clinical Laboratory Manager OR Lab Manager OR Laboratory Operations Manger in Central California
- Bakersfield, CA
- 8 days ago
- Bakersfield, CA
- 8 days ago
Laboratory Manager in Central California Location Highlights: Low cost of living area Access to a wide range of outdoor water activities like boating, fishing, swimming, waterskiing and beautiful...
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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
- Quality Systems
- Supplier Management
- Implementation
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Institutional Review Board
- Cell Biology
- Assay Development
- Transfection
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Clinical Laboratory Operations
- Cell Culture
- DNA Isolation
- Drug Development
- Biochemistry
- Microbiology
- Biology
- Stem Cells
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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