Director of Quality Assurance and Regulatory Affairs Jobs in Hawthorne, 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 (11 miles from Hawthorne, CA)
- 1 day ago
- Santa Monica, CA (11 miles from Hawthorne, CA)
- 1 day 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...
Research Scientist and Lab Manager
- Pasadena, CA (20 miles from Hawthorne, CA)
- 4 days ago
- Pasadena, CA (20 miles from Hawthorne, CA)
- 4 days ago
This job requires knowledge of basic principles of chemical engineering, electrochemical measurements, and molecular biology techniques....
- Anaheim, CA (22 miles from Hawthorne, CA)
- 8 days ago
- Anaheim, CA (22 miles from Hawthorne, CA)
- 8 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...
- Los Angeles, CA (6 miles from Hawthorne, CA)
- 14 days ago
- Los Angeles, CA (6 miles from Hawthorne, CA)
- 14 days ago
PCR, nucleic acid purification) and cell biology techniques (e.g., cell culture, microscopy)....
- Los Angeles, CA (6 miles from Hawthorne, CA)
- 15 days ago
- Los Angeles, CA (6 miles from Hawthorne, CA)
- 15 days ago
Budget Oversight: Oversee regulatory and international registration budgets Requirements Bachelor's degree in Chemistry, Biology, Life Sciences, or a related field; advanced degree preferred Minimum...
Lab Manager - Georgetown University College of Arts & Sciences
- Cypress, CA (18 miles from Hawthorne, CA)
- 15 days ago
- Cypress, CA (18 miles from Hawthorne, CA)
- 15 days ago
Requirements and Qualifications A minimum of a Bachelor's Degree in Psychology, Biology, Chemistry or other related field 1-2 years research experience in a psychology lab setting Previous experience...
- Los Angeles, CA (6 miles from Hawthorne, CA)
- 29 days ago
- Los Angeles, CA (6 miles from Hawthorne, CA)
- 29 days ago
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...
Master's degree in Chemistry, Biology, Toxicology, Pharmacology or equivalent preferred....
Demographic Data for Hawthorne, CA
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Director of Quality Assurance and Regulatory Affairss in Hawthorne, 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
- 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
- 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
- Scientific Writing
- 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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