Manager of Quality Assurance and Regulatory Affairs Jobs
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.
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Manager/Sr Manger/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) - Remote
- San Francisco, CA
- 8 hours ago
- San Francisco, CA
- 8 hours ago
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in...
Remote WorkUS Strategic Director - Regulatory Affairs
- Indianapolis, IN
- 22 hours ago
- Indianapolis, IN
- 22 hours ago
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe...
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA
- 22 hours ago
- Alameda, CA
- 22 hours ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Associate Director Regulatory Affairs Vascular (on-site)
- Saint Paul, MN
- 22 hours ago
- Saint Paul, MN
- 22 hours ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Director, Quality Assurance Operations Cambridge, MA Clinical Development, Quality Job Type Full-time Description Title: Director Quality Assurance Operations Marengo Therapeutics is pioneering...
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DESCRIPTION Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote...
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
Research Technician - ChBE Lab Manager (Bhamla Lab) Onsite
- Atlanta, GA
- 2 days ago
- Atlanta, GA
- 2 days ago
About Us Overview Georgia Tech prides itself on its technological resources, collaborations, high-quality student body, and its commitment to building an outstanding and diverse community of...
Director, Regulatory Affairs & Quality Assurance
- Manchester, NH
- 2 days ago
- Manchester, NH
- 2 days ago
Overview The mission of the Advanced Regenerative Manufacturing Institute (ARMI) is to advance the U.S. bioeconomy. ARMI is building a highly diverse, competitive, capable and innovative domestic...
Research Lab Manager - Neurosurgery Washington University in St. Louis
- Saint Louis, MO
- 3 days ago
- Saint Louis, MO
- 3 days ago
Scheduled Hours 40 Position Summary The Roland Lab is seeking an enthusiastic Research Lab Manager to join our study of brain networks in development and pathological conditions. Our work...
Clinical Laboratory Manager or Lab Manager in Southern Florida
- Homestead, FL
- 3 days ago
- Homestead, FL
- 3 days ago
NEW Laboratory Manager Opening available in the beautiful Southern Florida! This hospital is a brand new facility and offers a comprehensive range of services including (but not limited to)...
Laboratory Manager or Clinical Lab Manager Position in Georgia
- Dublin, GA
- 3 days ago
- Dublin, GA
- 3 days ago
NEW Laboratory Manager or Clinical Laboratory Manager opening at an Award Winning Health System in Georgia! This 150 bed, acute care hospital offers a comprehensive range of services including...
Manager of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities
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Manager of Quality Assurance and Regulatory Affairss 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
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Cloning
- Drug Development
- Clinical Laboratory Operations
- Genotyping
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- Western Blot
- 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
- Microsoft Office
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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