Director of Quality Assurance and Regulatory Affairs Jobs in Pasadena, 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.
- Torrance, CA (24 miles from Pasadena, CA)
- 15 days ago
- Torrance, CA (24 miles from Pasadena, CA)
- 15 days ago
Job Summary: The Quality Control Lab Manager will support the establishment and operation of our cGMP QC lab including but not limited to: Equipment receipt and installation, lab operations and...
Requirements: Bachelor's degree in Biochemistry, Chemistry, Biology, or related science discipline 7 years of relevant experience in pharmaceutical drug development 5 years in regulatory affairs in...
Director, Regulatory Affairs Strategy
- Los Angeles, CA (13 miles from Pasadena, CA)
- 30+ days ago
- Los Angeles, CA (13 miles from Pasadena, CA)
- 30+ days ago
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
- Los Angeles, CA (13 miles from Pasadena, CA)
- 30+ days ago
- Los Angeles, CA (13 miles from Pasadena, CA)
- 30+ days ago
Develop and execute regulatory strategies to support new product development, clinical trials, and global market access....
- Sylmar, CA (16 miles from Pasadena, CA)
- 30+ days ago
- Sylmar, CA (16 miles from Pasadena, CA)
- 30+ days ago
Develop and execute regulatory strategies to support new product development, clinical trials, and global market access....
Director of Quality Assurance - Cell and Gene Therapy Operations
- Duarte, CA (9 miles from Pasadena, CA)
- 90+ days ago
- Duarte, CA (9 miles from Pasadena, CA)
- 90+ 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...
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Director of Quality Assurance and Regulatory Affairss in Pasadena, 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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