Manager of Quality Assurance and Regulatory Affairs Jobs in Tennessee
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.
Principal Scientist (Director) - Regulatory Affairs-CMC
- Nashville, TN
- 2 days ago
- Nashville, TN
- 2 days ago
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Nashville, TN
- 6 days ago
- Nashville, TN
- 6 days ago
This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure...
Overview of the role This role provides timely and accurate analytical support to production, leadership and manages laboratory personnel in support of site operations with the objective of...
California, US residents click here (. **The job details are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit...
Labcorp is seeking a Clinical Laboratory Manager to join our team at University of Tennessee Medical Center in Knoxville, TN. This position will be responsible for overseeing the operations and...
Education: A Bachelor’s Degree [relevant scientific discipline, e.g., Medical/Clinical Laboratory Science, Biology, Chemistry, Biomedical Science] or a related field....
This person will also assist with coordination of organizational aspects, execution of clinical trials, technical measures and duties as assigned to serve the needs of Faculty & students participating...
Anatomy Lab Manager, DCOM - Orange Park Department: DCOM BASIC SCIENCES Position Category: Staff Full Time Job Description: The Anatomy Lab Facilities Manager for the Lincoln Memorial University...
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Manager of Quality Assurance and Regulatory Affairss in Tennessee 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
- Electrical Engineering
- Employee Development
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Drug Development
- Biology
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
- Process Development
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Investigation
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Regulations
- Inventory Management
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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