Director of Quality Assurance and Regulatory Affairs Jobs in Rockville, 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.
- Washington, DC (14 miles from Rockville, MD)
- 3 days ago
- Washington, DC (14 miles from Rockville, MD)
- 3 days ago
Director of Quality Assurance Location: Washington, D.C. Working Situation: Onsite This company is dedicated to promoting and protecting generational family farms by empowering farmers to make...
Associate Director, Regulatory Affairs (mRNA vaccines)
- Rockville, MD
- 7 days ago
- Rockville, MD
- 7 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Durham Blackwell Street, Rockville Vaccines, Upper Merion, Waltham Posted Date: Mar 5 2025 Are you looking for a highly...
The Senior Director, Regulatory Affairs will head the Regulatory function at MaxCyte. The Senior Director, Regulatory Affairs develops and implements regulatory compliance and strategies that...
Regulatory Affairs Manager- US Regulatory Lead
- Washington, DC (14 miles from Rockville, MD)
- 8 days ago
- Washington, DC (14 miles from Rockville, MD)
- 8 days ago
Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives...
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Mar 3 2025 Job Purpose Ensure the development of appropriate...
- Chantilly, VA (21 miles from Rockville, MD)
- 13 days ago
- Chantilly, VA (21 miles from Rockville, MD)
- 13 days ago
The Aerospace Corporation is the trusted partner to the nations space programs, solving the hardest problems and providing unmatched technical expertise. As the operator of a federally funded...
Materials Lab Manager and Lead Researcher
- McLean, VA (10 miles from Rockville, MD)
- 14 days ago
- McLean, VA (10 miles from Rockville, MD)
- 14 days ago
At Accenture Federal Services, nothing matters more than helping the US federal government make the nation stronger and safer and life better for people.Our 13,000+ people are united in a shared...
Regulatory Affairs Director - Global Regulatory Lead
- Washington, DC (14 miles from Rockville, MD)
- 26 days ago
- Washington, DC (14 miles from Rockville, MD)
- 26 days ago
Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Bethesda, MD (7 miles from Rockville, MD)
- 60+ days ago
- Bethesda, MD (7 miles from Rockville, MD)
- 60+ days ago
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...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Washington, DC (14 miles from Rockville, MD)
- 60+ days ago
- Washington, DC (14 miles from Rockville, MD)
- 60+ days ago
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 Rockville, MD
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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in Rockville, MD
Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Rockville, 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
- English
- Quality Systems
- Supplier Management
- Distribution
- Implementation
- Resolution
- Safe Quality Food
- Coaching
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Assay Development
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Drug Discovery
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Troubleshooting
- Quality Control
- Investigation
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Inventory Management
- Regulations
- Teaching
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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