Director of Quality Assurance and Regulatory Affairs Jobs

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 247 Jobs
Food Safety Net Services

Lab Manager

Certified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. The Certified Group of companies includes Food Safety Net...

Clinical Lab Manager

  • Bedford, IN
  • 6 hours ago
  • Bedford, IN
  • 6 hours ago

Indiana University Health is unlike any other healthcare system and we're looking for team members who share the things that matter most to us. People who are inspired by challenging and...

Research Lab Manager

  • New York, NY
  • 11 hours ago
  • New York, NY
  • 11 hours ago

biology, immunology, and animal model research Excellent organizational, analytical, and problem-solving abilities Proficiency in lab management systems and Microsoft Office Suite Knowledge of regulatory...

Instructional Lab Manager - Department of Biological Sciences

  • Clemson, SC
  • 11 hours ago
  • Clemson, SC
  • 11 hours ago

Serves on Department Instrumentation Committee and coordinates equipment shared across the three buildings housing Biology and Microbiology teaching labs.10% - Essential - Lab Safety: Serves as Department...

Lab Manager

  • San Francisco, CA
  • 16 hours ago
  • San Francisco, CA
  • 16 hours ago

Adhere to a prescribed schedule for cleaning tissue culture rooms, including hoods, incubators, and water baths. Handle biohazard and chemical waste according to OSHA standards....

Manager - Quality Assurance & Food Safety

  • Brockton, MA
  • 17 hours ago
  • Brockton, MA
  • 17 hours ago

Your Education & Experience: Bachelor’s Degree in Food Science, Biology, Microbiology, Chemistry, or related field. 5+ years in food manufacturing required, with 3+ years in the Technical and Quality...

Biology Lab Manager / Instructor

  • Albany, GA
  • 20 hours ago
  • Albany, GA
  • 20 hours ago

Job ID 286955 Location Columbus State University Department Dept Of Biology Business Unit Columbus State University Posted Date 06/18/2025...

Research Technologist-Lab Manager University of Nebraska Lincoln

  • Lincoln, NE
  • 1 day ago
  • Lincoln, NE
  • 1 day ago

Minimum Required Qualifications: Bachelor's degree in Biology and 1 year of laboratory experience. Strong experience with molecular biology and ordering supplies....

Senior Manager, Quality Assurance

  • Athens, OH
  • 1 day ago
  • Athens, OH
  • 1 day ago

The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in...

Senior Research Lab Manager - KSCIRC - R107019

  • Louisville, KY
  • 1 day ago
  • Louisville, KY
  • 1 day ago

Senior Research Lab Manager - KSCIRC - R107019 University of Louisville in Louisville, KY Apply Now Type: Full-Time Posted: 06/17/2025 Category: Laboratory and Research Department: Location:...

Associate Director, Regulatory Affairs

  • Boston, MA
  • 1 day ago
  • Boston, MA
  • 1 day ago

Regulatory Strategist - Advanced Therapeutics (Associate Director) Our biotech client is pioneering next-generation regenerative medicine and seeking a Regulatory Expert to lead efforts in...

Biology Lab Manager / Instructor

  • Columbus, GA
  • 1 day ago
  • Columbus, GA
  • 1 day ago

Department Information Department of Biology Job Summary Coordinates and oversees the acquisition, use, and maintenance of laboratory equipment and supplies; prepares and maintains materials used in...

Assistant Lab Manager

  • Cincinnati, OH
  • 1 day ago
  • Cincinnati, OH
  • 1 day ago

What You'll Do ECS Limited is offering a unique opportunity for a talented and certified Assistant Lab Manager to join our Cincinnati team. We offer opportunities for professional development with...

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

  • Frisco, TX
  • 2 days ago
  • Frisco, TX
  • 2 days ago

Biology Spec-ASCP (SMB):....

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...

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Salary for Director of Quality Assurance and Regulatory Affairs Jobs Nationwide

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 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
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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