Director of Quality Assurance and Regulatory Affairs Jobs in Los Angeles, 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.
Associate Director, Regulatory Affairs - CMC (Cell Therapy)
- Santa Monica, CA (14 miles from Los Angeles, CA)
- 16 days ago
- Santa Monica, CA (14 miles from Los Angeles, CA)
- 16 days 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...
- Anaheim, CA (18 miles from Los Angeles, CA)
- 23 days ago
- Anaheim, CA (18 miles from Los Angeles, CA)
- 23 days ago
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...
REGULATORY AFFAIRS MANAGER LOS ANGELES, CA Who We Are Tower 28 is a clean beauty brand born and bred in Santa Monica. All products are designed for sensitive skin, high-performance, and 100%...
Lab Manager - Georgetown University College of Arts & Sciences
- Cypress, CA (16 miles from Los Angeles, CA)
- 30+ days ago
- Cypress, CA (16 miles from Los Angeles, CA)
- 30+ days ago
Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just...
Linde Gas & Equipment Inc. Chemical Lab Manager Location\: Los Angeles, CA Linde Gas & Equipment Inc. is seeking a Chemical Lab Manager to join our team! The Chemical Lab Manager will lead a Team...
Director of Quality Assurance - Cell and Gene Therapy Operations
- Duarte, CA (19 miles from Los Angeles, CA)
- 45+ days ago
- Duarte, CA (19 miles from Los Angeles, CA)
- 45+ 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...
- Hawthorne, CA (7 miles from Los Angeles, CA)
- 60+ days ago
- Hawthorne, CA (7 miles from Los Angeles, CA)
- 60+ days ago
Position Summary The Manager, Regulatory Affairs will be responsible for managing regulatory requirements and in-market product compliance to maintain and further develop the regulatory capability...
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Los Angeles, 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
- Verbal Communication
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Assay Development
- Biomarkers
- Flow Cytometry
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Next-Generation Sequencing
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Biology
- Stem Cells
- Microbiology
- Biotechnology
- Clinical Trials
- Good Laboratory Practice
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Policy Development
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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