Manager of Quality Assurance and Regulatory Affairs Jobs in San Diego, 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.
Update maps and documentation for equipment, outlets, and work areas for the main lab, tissue culture room, and radioactive tissue culture room....
Requirements: Undergraduate degree in in Biology, Chemistry, Physical Sciences, or related discipline, or comparable experience. 10 years of experience including management of GxP Quality/Compliance...
Background Requirements: Bachelor's degree in bioengineering/biomedical engineering, biochemistry, chemistry, molecular biology, or related technical science discipline required....
Senior Director/ Executive Director, Regulatory Affairs
- San Diego, CA
- 4 days ago
- San Diego, CA
- 4 days ago
Fate Therapeutics is looking for an Executive Director or Senior Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities...
Payroll Title: LAB AST 2 Department: PSYCHOLOGY Hiring Pay Scale $22.03 - $25.90 / Hour Worksite: Campus Appointment Type: Limited Appointment Appointment Percent: 60-100% Union: TX Contract Total...
We are hiring in our Diagnostics Regulatory Affairs team here in San Diego, and are looking for a Regulatory Affairs Manager, responsible for on-market regulatory activities associated with US...
Education Bachelors degree in a scientific discipline: Engineering, Biology, etc. or equivalent. Advanced degree (Masters degree or higher) preferred....
Patience, knowledge and experience to teach principal laboratory operations, theories, molecular biology techniques, tissue culture operations and techniques, and laboratory safety procedures and policies...
The Position This position is responsible for supporting multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements and guidelines, and develop and execute...
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees,...
Summary Job Description Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery,...
Maintain all appropriate corporate standards for office and lab safety. Other duties as assigned....
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Manager of Quality Assurance and Regulatory Affairss in San Diego, 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
- 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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