Manager of Quality Assurance and Regulatory Affairs Jobs in Irvine, CA
A Manager of Quality Assurance and Regulatory Affairs in the biotechnology industry is responsible for ensuring that all products and services meet required standards and regulations. They ensure compliance with local, national, and international regulatory requirements, oversee quality control processes, and manage audits and inspections. This role also involves creating and implementing policies and procedures to enhance product quality, efficiency, and safety. They also play a crucial role in the product development process, advising on regulatory requirements and ensuring that compliance is maintained throughout the lifecycle of a product.
Skills required for this role include excellent attention to detail, strong organizational and leadership skills, and in-depth knowledge of regulatory standards and quality control methods. In addition, they should have excellent problem-solving skills, the ability to work under pressure, and strong communication skills. They should also have a strong understanding of biotechnology principles and processes. Certifications such as Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Regulatory Affairs Certification (RAC) are often required. Prior roles that can lead to a Manager of Quality Assurance and Regulatory Affairs include Quality Assurance Specialist, Regulatory Affairs Associate, and Quality Control Supervisor.
Director of Quality Assurance (Software)
- Aliso Viejo, CA (10 miles from Irvine, CA)
- 5 hours ago
- Aliso Viejo, CA (10 miles from Irvine, CA)
- 5 hours 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 (13 miles from Irvine, CA)
- 8 days ago
- Anaheim, CA (13 miles from Irvine, 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...
Lab Manager - Georgetown University College of Arts & Sciences
- Cypress, CA (17 miles from Irvine, CA)
- 15 days ago
- Cypress, CA (17 miles from Irvine, 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...
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...
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...
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Manager of Quality Assurance and Regulatory Affairss in Irvine, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager 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
- Transfection
- Cloning
- Clinical Laboratory Operations
- Cancer Biology
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Drug Development
- Biology
- 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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