Manager of Quality Assurance and Regulatory Affairs Jobs in East 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.
Senior Manager, Regulatory Affairs US Advertising and Promotion - Neuroscience
- East Irvine, CA
- 5 days ago
- East Irvine, CA
- 5 days ago
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive...
Senior Manager of Regulatory Affairs
- Irvine, CA (5 miles from East Irvine, CA)
- 8 days ago
- Irvine, CA (5 miles from East Irvine, CA)
- 8 days ago
Title: Regulatory Affairs Senior Manager Summary: Our client is seeking an experienced Senior Manager of Regulatory Affairs to lead the preparation and submission of global regulatory filings,...
Director, Regulatory Affairs CMC
- Irvine, CA (5 miles from East Irvine, CA)
- 17 days ago
- Irvine, CA (5 miles from East Irvine, CA)
- 17 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...
- Santa Ana, CA (7 miles from East Irvine, CA)
- 30+ days ago
- Santa Ana, CA (7 miles from East Irvine, CA)
- 30+ days ago
Experience in cell, tissues culture and/or embryology, a plus. Experience can be from education or industry. Ability to obtain cooperation from other groups and lead cross functional teams....
- Newport Beach, CA (7 miles from East Irvine, CA)
- 45+ days ago
- Newport Beach, CA (7 miles from East Irvine, CA)
- 45+ days ago
Evolus is a performance beauty company with a customer-centric approach focused on delivering breakthrough products.We are seeking an experienced and driven Regulatory Affairs Manager to join our...
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Salary for Manager of Quality Assurance and Regulatory Affairs Jobs in East Irvine, CA
Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in East 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
- 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
- Transfection
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Biochemistry
- Microbiology
- Biology
- Stem Cells
- Immunology
- 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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Manager of Quality Assurance and Regulatory Affairs Related Career Advice Articles
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