Manager of Quality Assurance and Regulatory Affairs Jobs in Mclean, VA
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.
- Washington, DC (7 miles from Mclean, VA)
- 2 days ago
- Washington, DC (7 miles from Mclean, VA)
- 2 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 (10 miles from Mclean, VA)
- 7 days ago
- Rockville, MD (10 miles from Mclean, VA)
- 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...
Senior Director, Regulatory Affairs
- Rockville, MD (10 miles from Mclean, VA)
- 8 days ago
- Rockville, MD (10 miles from Mclean, VA)
- 8 days ago
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 (7 miles from Mclean, VA)
- 8 days ago
- Washington, DC (7 miles from Mclean, VA)
- 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...
Director, Regulatory Affairs, Specialty
- Rockville, MD (10 miles from Mclean, VA)
- 9 days ago
- Rockville, MD (10 miles from Mclean, VA)
- 9 days ago
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 (15 miles from Mclean, VA)
- 13 days ago
- Chantilly, VA (15 miles from Mclean, VA)
- 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...
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 (7 miles from Mclean, VA)
- 26 days ago
- Washington, DC (7 miles from Mclean, VA)
- 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 (4 miles from Mclean, VA)
- 60+ days ago
- Bethesda, MD (4 miles from Mclean, VA)
- 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 (7 miles from Mclean, VA)
- 60+ days ago
- Washington, DC (7 miles from Mclean, VA)
- 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 Mclean, VA
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Salary for Manager of Quality Assurance and Regulatory Affairs Jobs in Mclean, VA
Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Mclean, VA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager 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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