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.

1-12 of 12 Jobs

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...

Lab Manager - Anatomic Pathology

  • Burlington, NC
  • 5 days ago
  • Burlington, NC
  • 5 days ago

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...

Senior Manager, Quality Assurance

  • Morrisville, NC
  • 8 days ago
  • Morrisville, NC
  • 8 days ago

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...

Associate Director, Quality Assurance

  • Durham, NC
  • 11 days ago
  • Durham, NC
  • 11 days ago

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,...

Lab Manager, Biology

  • Winston Salem, NC
  • 17 days ago
  • Winston Salem, NC
  • 17 days ago

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...

Lab Manager - Biotech Teaching

  • Raleigh, NC
  • 30+ days ago
  • Raleigh, NC
  • 30+ days ago

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...

Lab Manager - Cell Processing Lab

  • Charlotte, NC
  • 60+ days ago
  • Charlotte, NC
  • 60+ days ago

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

Moving to North Carolina? Find some basic demographic data about North Carolina below.


Local
National
10,439,413
246,359

Manager of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities

iHireBiotechnology curates thousands of courses in order to recommend the best ones to help further your career. If you register for a course using the links on our site, we may receive a small commission.
The complete guide to quality control and quality assurance
Ensuring excellence: the complete guide to quality control and quality assurance is a comprehensive course design to equip professional with the essential knowledge and skill required maintain to...
Regulatory Compliance for Biosimilars-Mastery Quiz
This comprehensive, 100+-question mastery quiz is designed for professionals in the biologics and biosimilars field who seek to deepen their understanding of regulatory compliance, quality...
ESG Investment and Assurance Certification
Introduction to ESG: Importance and Market TrendsExplore the growing significance of ESG in global finance and corporate governance.Understand key drivers behind ESG investing, including...

Title Synonyms

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Salary for Manager of Quality Assurance and Regulatory Affairs Jobs in North Carolina

Estimated salary range based on data from US Bureau of Labor Statistics (BLS) and iHireBiotechnology research efforts.

Licensing / Certification

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 background
Bachelor's Degree
35.8%
Master's Degree
31.6%
Doctorate Degree
25.9%
Associate's Degree
2.8%
Vocational Degree or Certification
1.7%
High School or GED
1.5%
Some College
0.5%
Some High School
0.1%

Average Work Experience
Here's a breakdown of the number of years' experience offered by Manager of Quality Assurance and Regulatory Affairss in North Carolina
2-4 years
32.1%
4-6 years
32.1%
8-10 years
14.3%
6-8 years
10.7%
10+ years
7.1%
1-2 years
3.6%



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