Director of Quality Assurance and Regulatory Affairs Jobs in Germantown, MD
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.
Director of Regulatory Affairs
- Frederick, MD (22 miles from Germantown, MD)
- 5 days ago
- Frederick, MD (22 miles from Germantown, MD)
- 5 days ago
Must possess excellent written and oral communication skills and clinical trial fieldwork concepts and practices....
Manager, Quality Assurance - Clinical Trials (Hybrid)
- Chantilly, VA (19 miles from Germantown, MD)
- 13 days ago
- Chantilly, VA (19 miles from Germantown, MD)
- 13 days ago
Apply knowledge of regulatory requirements on a daily basis including providing guidance on interpretation of, and compliance with, regulatory requirements (GCPs, CLIA), guidance, Good Clinical Practice...
Associate Director, Regulatory Affairs
- Washington, DC (21 miles from Germantown, MD)
- 14 days ago
- Washington, DC (21 miles from Germantown, 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...
- Washington, DC (21 miles from Germantown, MD)
- 16 days ago
- Washington, DC (21 miles from Germantown, 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, we're all a part of something bigger than...
Lab Manager Georgetown University
- Washington, DC (21 miles from Germantown, MD)
- 18 days ago
- Washington, DC (21 miles from Germantown, MD)
- 18 days ago
Lab Manager Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol...
Associate Director, Regulatory Affairs - Cmc (Cell Therapy)
- Gaithersburg, MD (5 miles from Germantown, MD)
- 18 days ago
- Gaithersburg, MD (5 miles from Germantown, 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...
- Washington, DC (21 miles from Germantown, MD)
- 18 days ago
- Washington, DC (21 miles from Germantown, MD)
- 18 days 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 Regulatory Affairs Director
- Gaithersburg, MD (5 miles from Germantown, MD)
- 30+ days ago
- Gaithersburg, MD (5 miles from Germantown, 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...
- Washington, DC (21 miles from Germantown, MD)
- 30+ days ago
- Washington, DC (21 miles from Germantown, MD)
- 30+ days ago
Certifications: --- Preferred Qualifications Education: Bachelor's degree or equivalent in Biology....
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....
Director, Quality Assurance (Compliance)
- Chantilly, VA (19 miles from Germantown, MD)
- 90+ days ago
- Chantilly, VA (19 miles from Germantown, MD)
- 90+ days ago
Job Type Full-time Description **US Based Candidates Only** Granules Pharmaceuticals, Inc., located in Chantilly, VA was the 10th fastest growing generic pharma company in United States in 2024...
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Director of Quality Assurance and Regulatory Affairss in Germantown, MD offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Quality Assurance and Regulatory Affairs position
- Mentoring
- Electrical Engineering
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Drug Development
- Biology
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Research and Development
- Process Development
- Diagnostic
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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