Director of Quality Assurance and Regulatory Affairs Jobs in Cypress, 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.
Director of Quality Assurance (Software)
- Aliso Viejo, CA (24 miles from Cypress, CA)
- 5 days ago
- Aliso Viejo, CA (24 miles from Cypress, CA)
- 5 days ago
Compensation: $165,000 - $195,000 per year. You are eligible for a Short-Term Incentive Plan with the target at 20% of your annual earnings; terms and conditions apply. Director of Quality,...
- Anaheim, CA (5 miles from Cypress, CA)
- 13 days ago
- Anaheim, CA (5 miles from Cypress, CA)
- 13 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 (16 miles from Cypress, CA)
- 20 days ago
- Los Angeles, CA (16 miles from Cypress, CA)
- 20 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
- 20 days ago
- Cypress, CA
- 20 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...
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- Los Angeles, CA (16 miles from Cypress, CA)
- 30+ days ago
- Los Angeles, CA (16 miles from Cypress, CA)
- 30+ 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...
Director of Quality Assurance - Cell and Gene Therapy Operations
- Duarte, CA (22 miles from Cypress, CA)
- 30+ days ago
- Duarte, CA (22 miles from Cypress, CA)
- 30+ 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...
Senior Manager of Regulatory Affairs
- Irvine, CA (17 miles from Cypress, CA)
- 30+ days ago
- Irvine, CA (17 miles from Cypress, CA)
- 30+ days ago
The Senior Manager should have the following qualifications: Bachelor's degree in a scientific discipline (engineering, biology, etc.). 5-8 years of regulatory experience in medical devices, preferably...
Director, Regulatory Affairs CMC
- Irvine, CA (17 miles from Cypress, CA)
- 45+ days ago
- Irvine, CA (17 miles from Cypress, CA)
- 45+ days ago
About the Role The Director, Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) will lead the development and execution of CMC regulatory strategy for the Company's assets. This...
- Hawthorne, CA (18 miles from Cypress, CA)
- 60+ days ago
- Hawthorne, CA (18 miles from Cypress, CA)
- 60+ days ago
Master's degree in Chemistry, Biology, Toxicology, Pharmacology or equivalent preferred....
Demographic Data for Cypress, CA
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Cypress, 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
- Affirmative Action
- Quality Systems
- Implementation
- Resolution
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Good Clinical Practice
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Bioinformatics
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Clinical Trials
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- 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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