Director of Quality Assurance and Regulatory Affairs Jobs in Maryland

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.

1-11 of 11 Jobs

Manager, Quality Assurance

  • Baltimore, MD
  • 8 hours ago
  • Baltimore, MD
  • 8 hours ago

Overview As a senior member of the quality assurance team, you will work collaboratively with laboratory personnel and groups throughout the organization to ensure compliance with regulatory...

Principal Scientist (Director) - Regulatory Affairs-CMC

  • Annapolis, MD
  • 2 days ago
  • Annapolis, MD
  • 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...

Director of Regulatory Affairs

  • Frederick, MD
  • 5 days ago
  • Frederick, MD
  • 5 days ago

Must possess excellent written and oral communication skills and clinical trial fieldwork concepts and practices....

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...

Associate Director, Regulatory Affairs

  • Annapolis, MD
  • 14 days ago
  • Annapolis, MD
  • 14 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

  • Annapolis, MD
  • 16 days ago
  • Annapolis, MD
  • 16 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...

Associate Director, Regulatory Affairs - Cmc (Cell Therapy)

  • Gaithersburg, MD
  • 18 days ago
  • Gaithersburg, MD
  • 18 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...

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
  • 45+ days ago
  • Aberdeen Proving Ground, MD
  • 45+ 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 Clinical and Pharmacovigilance (PV)

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

Partner closely with Clinical and Pharmacovigilance functions to support compliant execution of clinical trials and pre- and post-marketing pharmacovigilance activities....

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...

Demographic Data for Maryland

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


Local
National
6,176,902
140,318

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



Highest Education Level

Director 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
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 Director 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%



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