Manager of Quality Assurance and Regulatory Affairs Jobs in California
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.
Career Category Regulatory Job Description HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How...
The Director of Regulatory Affairs for the US & Canada for American Vanguard / AMVAC will lead the US Regulatory Team to ensure that FIFRA Federal and State and Canadian regulatory requirements...
PREFERRED QUALIFICATIONS Patience, knowledge and experience to teach principal laboratory operations, theories, molecular biology techniques, tissue culture operations and techniques, and laboratory...
Manager, Quality Assurance, Product Complaint
- San Francisco, CA
- 2 days ago
- San Francisco, CA
- 2 days ago
This position will manage product quality complaints for commercial marketed products and clinical trial materials....
Unlike CAR-T and any genetically modified cell therapy, AlloNK is a non-genetically modified NK cell therapy candidate and has not shown any secondary malignancies in our clinical trials, which is a...
Unlike CAR-T and any genetically modified cell therapy, AlloNK is a non-genetically modified NK cell therapy candidate and has not shown any secondary malignancies in our clinical trials, which is a...
Deep understanding of clinical trial requirements for initial INDs/CTAs for all development phases early to late-stage....
Our journey into the realm of clinical trials was ignited by a firsthand understanding of the challenges involved....
Title: Senior Director Regulatory Affairs SUMMARY: A leading biopharmaceutical company is seeking a Sr. Director of Regulatory Affairs. This role involves developing and implementing global...
Overview * All positions are located in Fresno/Clovis CA * *Up to $10k sign-on bonus available for qualified candidates * At Community Health System, we know that our ability to provide the...
Senior Quality Assurance Manager/Quality Assurance Director
- South San Francisco, CA
- 4 days ago
- South San Francisco, CA
- 4 days ago
trial protocol, regulatory filings and product specific requirements Note: This position may be hired at either a Senior Manager or Director level, depending on candidate qualifications....
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...
Associate Director, Quality Assurance and Compliance
- San Carlos, CA
- 7 days ago
- San Carlos, CA
- 7 days ago
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases,...
Lab Manager (9602C) 76850 University of California, Berkeley
- Berkeley, CA
- 7 days ago
- Berkeley, CA
- 7 days ago
The Lab Manager will assist lab members with their experiments in molecular biology and animal work....
The Lab Manager will assist lab members with their experiments in molecular biology and animal work....
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Manager of Quality Assurance and Regulatory Affairss in California 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
- Quality Systems
- Supplier Management
- Implementation
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Institutional Review Board
- Cell Biology
- Assay Development
- Flow Cytometry
- Real-Time Polymerase Chain Reaction
- Transfection
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Drug Development
- Clinical Laboratory Operations
- Cell Culture
- Genotyping
- DNA Isolation
- Biochemistry
- Microbiology
- Biology
- Stem Cells
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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