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.
Job Title: Associate Director, Regulatory Affairs Location: San Diego, CA / Hybrid / Remote Position type: FLSA: Full time Exempt Department: Finance ID: Regulatory 8300-Q224-9 Strive to Bring a...
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,...
collaborate cross-functionally with Facilities, IT, R&D, Quality, Sourcing, and Finance teams Mentor and cross-train Lab Operations team members as needed Education and Experience: Bachelors degree in Biochemistry...
Sr. Director, Quality & Regulatory Compliance, Compliance Programs
- San Diego, CA
- 30+ days ago
- San Diego, CA
- 30+ days ago
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,...
Director, Quality & Regulatory Compliance, Compliance Programs
- San Diego, CA
- 30+ days ago
- San Diego, CA
- 30+ days ago
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,...
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,...
Senior Director Regulatory Affairs Ad/Promo City : San Diego State : CA Country : US Job Term : Permanent Overview : PharmaLogics Recruiting is seeking a Senior Director, Regulatory Affairs...
Job Description: We are seeking a highly motivated and qualified individual to join our growing organization as an on-site Associate Director / Director, Regulatory Affairs and work as part of a...
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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
- English
- Quality Systems
- Supplier Management
- Distribution
- Implementation
- Resolution
- Safe Quality Food
- Coaching
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Assay Development
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Drug Discovery
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Troubleshooting
- Quality Control
- Investigation
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Inventory Management
- Regulations
- Teaching
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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