Manager of Quality Assurance and Regulatory Affairs Jobs

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 267 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...

Lab Manager - Blood Bank and Transfusion Medicine

  • New Orleans, LA
  • 45+ days ago
  • New Orleans, LA
  • 45+ days ago

We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate, and innovate. We believe that every award earned,...

Regulatory Affairs Manager - Electrophysiology (on-site)

  • Plymouth, MN
  • 12 days ago
  • Plymouth, MN
  • 12 days ago

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...

Regulatory Affairs Manager Heart Failure (on-site)

  • Pleasanton, CA
  • 45+ days ago
  • Pleasanton, CA
  • 45+ days ago

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...

Lab Manager

  • South San Francisco, CA
  • moments ago
  • South San Francisco, CA
  • moments 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....

Lab Manager

  • Raleigh, NC
  • 5 hours ago
  • Raleigh, NC
  • 5 hours 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 of Regulatory Affairs

  • Berkeley, CA
  • 8 hours ago
  • Berkeley, CA
  • 8 hours ago

About Us Ray Therapeutics is a clinical-stage biopharmaceutical company developing therapies to restore vision in patients affected with retinal degenerations. RayTx utilizes optogenetics to...

Associate Director, Regulatory Affairs - Cmc (Cell Therapy)

  • Gaithersburg, MD
  • 8 hours ago
  • Gaithersburg, MD
  • 8 hours ago

The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of Cell...

Director, Quality Assurance (QS&C)

  • Vista, CA
  • 9 hours ago
  • Vista, CA
  • 9 hours ago

A brief overview The Director of Quality Assurance (Quality Systems & Compliance), in conjunction with the VP of Quality, maintains systems to assure compliance regulatory and client requirements...

Quantitative Ecology Lab Manager (SRA 3)

  • Davis, CA
  • 9 hours ago
  • Davis, CA
  • 9 hours ago

Quantitative Ecology Lab Manager (SRA 3) University of California - Davis vision insurance, parental leave, paid time off, paid holidays, sick time, long term disability, tuition reimbursement...

Regulatory Affairs Manager/Sr (Remote)

  • Princeton, NJ
  • 9 hours ago
  • Princeton, NJ
  • 9 hours ago

Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials Supports Head of Department in business development activities including the preparation of client proposals...

Remote Work

Lab Manager

  • Washington, DC
  • 11 hours ago
  • Washington, DC
  • 11 hours ago

Georgetown University comprises two unique campuses in the nations capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just...

Senior Manager, Quality Assurance (M-F Day Shift)

  • Bloomington, IN
  • 11 hours ago
  • Bloomington, IN
  • 11 hours ago

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on...

Manager, Quality Assurance (PM or Weekend Shift)

  • Bloomington, IN
  • 11 hours ago
  • Bloomington, IN
  • 11 hours ago

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on...

Senior Director, Regulatory Affairs (CMC)

  • Brisbane, CA
  • 13 hours ago
  • Brisbane, CA
  • 13 hours ago

Position Summary: Ultragenyx is seeking a highly motivated Senior Director, Regulatory Affairs CMC, who is a team builder and enjoys a fast-paced, dynamic work environment. In this position, the...

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...

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



Highest Education Level

Manager 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 Manager 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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