Director of Quality Assurance and Regulatory Affairs Jobs in North Carolina

A Director of Quality Assurance and Regulatory Affairs in the biotechnology industry is essentially responsible for developing and implementing systems that ensure products meet quality standards and regulatory requirements. This includes conducting internal audits, leading investigations into quality issues, liaising with regulatory bodies, and overseeing the submission of regulatory documents. They are also responsible for ensuring compliance with regulatory requirements and standards such as ISO, FDA, and EMEA. They play a crucial role in maintaining the company's reputation and ensuring customer satisfaction by ensuring that products are safe, reliable, and meet both customer and regulatory requirements.

Key skills for this role include strong analytical and problem-solving skills, excellent communication skills, and a strong knowledge of the biotechnology industry and its associated regulations. They should also have strong leadership skills, as they will often be leading teams and coordinating with other departments. Important certifications may include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC), or Certified Quality Manager (CQM). Prior to becoming a Director of Quality Assurance and Regulatory Affairs, an individual may have roles such as Quality Assurance Manager, Regulatory Affairs Specialist, or Senior Quality Engineer within the industry.

1-15 of 15 Jobs

Lab Manager for the Department of Chemistry

  • Elon, NC
  • 1 day ago
  • Elon, NC
  • 1 day ago

Title: Lab Manager for the Department of Chemistry Position Type: Staff Full-Time Days Per Week: Monday - Friday Hours Per Week: 40 VP Area: Office of the Provost and Academic Affairs Department:...

Senior Director, Regulatory Affairs

  • Morrisville, NC
  • 2 days ago
  • Morrisville, NC
  • 2 days ago

About Kriya Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary...

Associate Director, Regulatory Affairs

  • Raleigh, NC
  • 2 days ago
  • Raleigh, NC
  • 2 days ago

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...

Supervisory Clinical Laboratory Scientist (Lab Manager)

  • Fayetteville, NC
  • 4 days ago
  • Fayetteville, NC
  • 4 days 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

  • Raleigh, NC
  • 6 days ago
  • Raleigh, NC
  • 6 days ago

We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, were all a part of something bigger than...

Senior Manager, Quality Assurance

  • Morrisville, NC
  • 12 days ago
  • Morrisville, NC
  • 12 days ago

Biology and Virology testing....

Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)

  • Durham, NC
  • 14 days ago
  • Durham, NC
  • 14 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
  • 15 days ago
  • Durham, NC
  • 15 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
  • 16 days ago
  • Durham, NC
  • 16 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
  • 17 days ago
  • Research Triangle Park, NC
  • 17 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
  • 18 days ago
  • Raleigh, NC
  • 18 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
  • 21 days ago
  • Winston Salem, NC
  • 21 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

Director 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

Users interested in this job title also searched for the following job titles


Salary for Director 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 Director of Quality Assurance and Regulatory Affairs positions.



Highest Education Level

Director 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 Director 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%



Director of Quality Assurance and Regulatory Affairs Related Career Advice Articles

Biotech career options - genetic research
4 Biotech Opportunities & Career Paths With High Growth Potential

Biotechnology is an emerging segment of the employment market with opportunities spanning healthcare, biopharmaceuticals, agriculture, industry, and academia. If you have a thirst for innovation, this career path might be right for you!

Read article »