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.
Assoc Director Quality Assurance, GCP (contract)
- San Diego, CA
- 3 hours ago
- San Diego, CA
- 3 hours ago
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...
About this opportunity : The Director, Quality Assurance GMP Operations is responsible for quality oversight of the manufacturing process and operations. This includes leading and managing...
Scheduled Hours 40 Position Summary Serves as quality and safety leader for department's Neuromuscular Clinical Laboratory ensuring the effectiveness and proper execution of procedures, processes...
Background Requirements: Bachelor's degree in bioengineering/biomedical engineering, biochemistry, chemistry, molecular biology, or related technical science discipline required....
Employment type: Full-time, exempt, onsite Location: Athens, GA About Blue Lake Biotechnology, Inc. Blue Lake Biotechnology is a private intranasal vaccine company harnessing the full breadth of...
Primary City/State:** Phoenix, Arizona **Department Name:** General Lab-Days-Ref Lab **Work Shift:** Day **Job Category:** Lab Your pay and benefits are important components of your journey at...
Director Quality Assurance Operations Req ID #: 226324 Memphis, TN, US; Memphis, TN, US Full time For 75 years, Charles River employees have worked together to assist in the discovery, development...
Proven to Perform. From the edges of space to the bottoms of ocean, our materials are proven to perform -- and so is our team. We're hiring high performers as proven as our products. Join us. We...
Manager Quality Assurance I - Neurology Washington University in St. Louis
- Saint Louis, MO
- 1 day ago
- Saint Louis, MO
- 1 day ago
Scheduled Hours 40 Position Summary Serves as quality and safety leader for departmentas Neuromuscular Clinical Laboratory ensuring the effectiveness and proper execution of procedures, processes...
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Thermo Fisher Scientific Inc. as a Clinical Trial Reg Affairs Manager specializing in medical devices and...
This is a full time, 18 month term position (expected to start in July 2025 and last through December 2026) Skills, Qualifications & Requirements: Required Qualifications: Undergraduate degree in biology...
Preparing tissue for use in downstream research investigations such as PCR, Cell culture, etc.). Performing direct and indirect immunohistochemistry on cell culture and tissue specimens....
Executive Director Quality Assurance Bioanalytical and Vaccine Laboratories
- Richmond, VA
- 2 days ago
- Richmond, VA
- 2 days ago
Qualifications & Requirements: Education & Experience Bachelors degree in Life Sciences, Chemistry, Biochemistry, Medical Technology, or a related field (Masters or Ph.D. preferred) 10+ years of experience...
Associate Regulatory Affairs Director Introduction to role The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities...
Labcorp is seeking a Clinical Laboratory Manager, Microbiology to join our team in Dublin, OH. This position will be responsible for overseeing the operations and administration of the clinical...
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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
- Mentoring
- Quality Systems
- Implementation
- 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
- Transfection
- 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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