Manager of Quality Assurance and Regulatory Affairs Jobs in North Carolina
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.
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...
Experience in lab safety procedures and maintaining a safe work environment....
Molecular Lab Manager - Tuesday-Saturday (3:00pm-11:30pm)
- Durham, NC
- 12 days ago
- Durham, NC
- 12 days ago
Passionate about precision medicine and advancing the healthcare industry? With the advent of genomic sequencing, we can finally decode and process our genetic makeup. We now have more data than...
Job Summary The Cell Processing Lab Manager is an integral leader within our growing cross-market Transplantation and Cellular Therapy Program. Oversees all aspects of the Novant Health Weisiger...
Creo Director, Quality and Regulatory Compliance in Durham , North Carolina JOB DESCRIPTION OVERVIEW The Director, Quality and Regulatory Compliance, will lead a team responsible for delivering...
Labcorp is seeking a Clinical Laboratory Manager to join our team in Burlington, NC. This position will be responsible for overseeing the operations and administration of the clinical laboratory...
Lecturer/Lab Manager - Applied Engineering Technology
- Greensboro, NC
- 90+ days ago
- Greensboro, NC
- 90+ days ago
The College houses the departments of Applied Engineering Technology, Biology, Built Environment, Chemistry, Computer Systems Technology, Mathematics and Statistics, Physics, and the Ph.D....
Regulatory Science Lead (Associate Director of Regulatory Affairs)
- Raleigh, NC
- 90+ days ago
- Raleigh, NC
- 90+ days ago
Make your mark for patients We are looking for a Regulatory Science Lead (Associate Director of Regulatory Affairs) who is a proactive, collaborative, and strategically minded individual to join...
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Manager of Quality Assurance and Regulatory Affairss in North Carolina 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
- Change Control
- 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
- 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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