Manager of Quality Assurance and Regulatory Affairs Jobs in Maryland

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.

1-10 of 10 Jobs

Associate Director, Regulatory Affairs - Cmc (Cell Therapy)

  • Gaithersburg, MD
  • 8 days ago
  • Gaithersburg, MD
  • 8 days 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, Regulatory Affairs, Regulatory Science & Execution

  • Gaithersburg, MD
  • 20 days ago
  • Gaithersburg, MD
  • 20 days ago

This is what you will do: The Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for...

Senior Regulatory Affairs Director

  • Gaithersburg, MD
  • 30+ days ago
  • Gaithersburg, MD
  • 30+ days ago

AstraZeneca - Vaccines & Immune Therapies At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of...

Experimental Mechanics of Materials Test Lab Manager

  • Aberdeen Proving Ground, MD
  • 30+ days ago
  • Aberdeen Proving Ground, MD
  • 30+ days ago

Join Us in Making a Difference in the Lives of Those Defending Our Nation! Why SURVICE? Come join the SURVICE Engineering mission to protect, enhance, and enable those who defend the United...

Manager, Quality Assurance

  • Gaithersburg, MD
  • 30+ days ago
  • Gaithersburg, MD
  • 30+ days ago

Qualifications: BS or BA degree in Biology, Chemistry or other relevant degree. At least 5 years experience in the CRO industry and 3 years supervisory experience or equivalent experience....

Director, Regulatory Affairs - CMC (Cell Therapy)

  • Gaithersburg, MD
  • 45+ days ago
  • Gaithersburg, MD
  • 45+ days ago

The Director, Regulatory Affairs - CMC (CGT) is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of AstraZeneca's C...

Regulatory Affairs Manager

  • Frederick, MD
  • 45+ days ago
  • Frederick, MD
  • 45+ days ago

You should have: B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related science At least 5 years of IVD Regulatory Affairs experience Hands-on experience with 510(k), PMA,...

Manager Quality Assurance Clinical and Pharmacovigilance (PV)

  • Germantown, MD
  • 60+ days ago
  • Germantown, MD
  • 60+ days ago

Manager Quality Assurance Clinical and Pharmacovigilance (PV) Job Description Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene...

Regulatory Affairs Manager

  • Fort Detrick, MD
  • 90+ days ago
  • Fort Detrick, MD
  • 90+ days ago

Overview LMI is seeking an experienced Regulatory Affairs Manager to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft. Detrick in...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...

Demographic Data for Maryland

Moving to Maryland? Find some basic demographic data about Maryland below.


Local
National
6,176,902
140,318

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

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


Salary for Manager of Quality Assurance and Regulatory Affairs Jobs in Maryland

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 Maryland 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 Maryland
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%



Manager 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 »