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.

1-15 of 18 Jobs

Senior Director Regulatory Affairs Pharmacy Automation Platform

  • Davis, NC
  • 14 hours ago
  • Davis, NC
  • 14 hours ago

development organizations Ensure Regulatory resources are available to support inspections conducted by global regulators Qualifications: M.S. degree in a technical discipline (e.g., engineering, biology...

Principal Scientist (Director) - Regulatory Affairs-CMC

  • Raleigh, NC
  • 2 days ago
  • Raleigh, NC
  • 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 Director, Regulatory Affairs

  • Morrisville, NC
  • 3 days ago
  • Morrisville, NC
  • 3 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...

Director, Quality Assurance

  • Durham, NC
  • 4 days ago
  • Durham, NC
  • 4 days ago

Minimum Requirements: Knowledge, Skills, Abilities Bachelor degree in pharmaceutical science, biology, chemistry, engineering or related science. 10 years work experience in pharmaceuticals and/or biologics...

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...

Lab Manager for the Department of Chemistry Elon University

  • Elon, NC
  • 12 days ago
  • Elon, NC
  • 12 days ago

Lab Manager for the Department of Chemistry Location: Elon University Campus Title: Lab Manager for the Department of Chemistry Position Type: Staff Full-Time Days Per Week: Monday - Friday Hours...

Lab Manager for the Department of Chemistry

  • Elon, NC
  • 14 days ago
  • Elon, NC
  • 14 days 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
  • 14 days ago
  • Morrisville, NC
  • 14 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
  • 15 days ago
  • Raleigh, NC
  • 15 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...

Lab Manager

  • Raleigh, NC
  • 18 days ago
  • Raleigh, NC
  • 18 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...

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

  • Durham, NC
  • 27 days ago
  • Durham, NC
  • 27 days ago

Capable of organising and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority Extensive knowledge of clinical trial and licensing...

Associate Director, Quality Assurance

  • Durham, NC
  • 27 days ago
  • Durham, NC
  • 27 days ago

Durham, NC Job Details Full-time Estimated: $113K - $148K a year 1 day ago Qualifications Bachelor of Science English 8 years Bachelor's degree Quality control QA/QC Clinical trials Good Clinical Practice...

Sr. Manager, Quality Assurance- Site Investigations Lead

  • Durham, NC
  • 28 days ago
  • Durham, NC
  • 28 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
  • 29 days ago
  • Research Triangle Park, NC
  • 29 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
  • 30+ days ago
  • Raleigh, NC
  • 30+ days ago

Minimum Education and Experience: Relevant Baccalaureate (4-year) degree in Food Science, Chemistry, Biology, Engineering, or a related field or a bachelors degree plus alternative or equivalent professional...

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...
Process-Validation: Essentials for Quality Assurance
Process-Validation: Essentials for Quality Assurance is a focused, practice-based course that turns (FDA PV Guidance, EU GMP Annex 15, ISO 13485, ICH Q9/Q10) validation theory into everyday plant...
Foundations of Pharmaceutical Quality Assurance and GMP
This comprehensive course covers everything you need to know about Quality Assurance (QA) in the pharmaceutical industry. You will learn the essential principles of Good Manufacturing Practices...

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
26.0%
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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