Manager of Quality Assurance and Regulatory Affairs Jobs in Gaithersburg, MD
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.
Director, Regulatory Affairs - CMC (Cell Therapy)
- Gaithersburg, MD
- 3 days ago
- Gaithersburg, MD
- 3 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...
Director of Regulatory Affairs
- Frederick, MD (23 miles from Gaithersburg, MD)
- 17 days ago
- Frederick, MD (23 miles from Gaithersburg, MD)
- 17 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 (22 miles from Gaithersburg, MD)
- 25 days ago
- Chantilly, VA (22 miles from Gaithersburg, MD)
- 25 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 (18 miles from Gaithersburg, MD)
- 27 days ago
- Washington, DC (18 miles from Gaithersburg, MD)
- 27 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 (18 miles from Gaithersburg, MD)
- 29 days ago
- Washington, DC (18 miles from Gaithersburg, MD)
- 29 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...
Director, Quality Assurance (Compliance)
- Chantilly, VA (22 miles from Gaithersburg, MD)
- 90+ days ago
- Chantilly, VA (22 miles from Gaithersburg, 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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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Gaithersburg, MD 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
- Mentoring
- Continuous Improvement
- Affirmative Action
- Quality Systems
- Implementation
- Quality Management
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- TrackWise
- Institutional Review Board
- ICH GCP
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Neurobiology
- Clinical Laboratory Operations
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Experimental Design
- Biotechnology
- Scientific Writing
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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