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.
Supervisory Clinical Laboratory Scientist (Lab Manager)
- Fayetteville, NC
- 1 day ago
- Fayetteville, NC
- 1 day ago
Summary The Supervisor serves as a Supervisory Clinical Laboratory Scientist for the Pathology and Laboratory Medicine Service (P&LMS) at the Fayetteville VA Medical Center and/or Satellite...
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...
Biology and Virology testing....
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Durham, NC
- 11 days ago
- Durham, NC
- 11 days ago
Site Name: Durham Blackwell Street, USA - Pennsylvania - Upper Providence Posted Date: Jun 10 2025 Job Purpose Ensure the development of appropriate regional regulatory strategy(s) and their...
Other: Expert knowledge and understanding of ICH E6 (R2) Good Clinical Practice Guidance, Title 21 of the Code of Federal Regulations, and good industry practices involving Quality....
Sr. Manager, Quality Assurance- Site Investigations Lead
- Durham, NC
- 13 days ago
- Durham, NC
- 13 days ago
This position is a full-time on-site role (M-F business hours) About This Role The Site Investigations Lead (SIL), Quality Assurance, is responsible for championing the overall investigations...
Sr. Manager, Quality Assurance- Site Investigations Lead
- Research Triangle Park, NC
- 14 days ago
- Research Triangle Park, NC
- 14 days ago
This position is a full-time on-site role (M-F business hours) About This Role The Site Investigations Lead (SIL), Quality Assurance, is responsible for championing the overall investigations...
Lab Manager - Food, Bioprocessing & Nutrition Sciences
- Raleigh, NC
- 15 days ago
- Raleigh, NC
- 15 days ago
The Department of Food, Bioprocessing and Nutrition Sciences (FBNS) encompasses diverse disciplines in research extension and teaching. Our programs combine the disciplines of chemistry,...
External Applicants: Please ensure all required documents are ready to upload before beginning your application, including your resume, cover letter, and any additional materials specified in the...
The incumbent will need to have working knowledge of biotechnology research materials, equipment, reagents, and mammalian cell culture sterile technique....
Manager, Quality Assurance Audits and Supplier Qualifications
- Morrisville, NC
- 45+ days ago
- Morrisville, NC
- 45+ days ago
Current and strong working knowledge, interpretation, and implementation of United States FDA Regulations, ICH Guidelines, and other local government regulatory requirements governing biopharmaceutical...
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...
Demographic Data for North Carolina
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Salary for Manager of Quality Assurance and Regulatory Affairs Jobs in North Carolina
Required or preferred licenses and certifications for Manager of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
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
- Quality Management
- Change Control
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Institutional Review Board
- ICH GCP
- Assay Development
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Next-Generation Sequencing
- Polymerase Chain Reaction
- Drug Development
- Western Blot
- Biochemistry
- Biology
- Pharmacovigilance
- Immunology
- Microbiology
- Scientific Writing
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- General Repair
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Collaboration
- Documentation
- Quality Assurance
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Regulations
- Inventory Management
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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Manager of Quality Assurance and Regulatory Affairs Related Career Advice Articles
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