Director of Quality Assurance and Regulatory Affairs Jobs in Silver Spring, 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.
About the Position The Research Laboratory Manager supports the Principal Investigator with the execution and maintenance of the research study, and the management of study documentation. The...
Exec Director, Regulatory Affairs-Combination Products & Devices
- Washington, DC (9 miles from Silver Spring, MD)
- 12 days ago
- Washington, DC (9 miles from Silver Spring, MD)
- 12 days ago
In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of small molecules and biologics....
Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution
- Gaithersburg, MD (12 miles from Silver Spring, MD)
- 19 days ago
- Gaithersburg, MD (12 miles from Silver Spring, MD)
- 19 days ago
At AstraZeneca's Alexion division, we push boundaries in rare disease biopharma by translating complex biology into transformative medicines....
- Alexandria, VA (14 miles from Silver Spring, MD)
- 20 days ago
- Alexandria, VA (14 miles from Silver Spring, MD)
- 20 days ago
Assistant Meats Lab Manager page is loaded Assistant Meats Lab Manager locations 0116 J.B. Francioni Jr. Hall time type Full time posted on Posted Today time left to apply End Date: November 26,...
Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution
- Gaithersburg, MD (12 miles from Silver Spring, MD)
- 22 days ago
- Gaithersburg, MD (12 miles from Silver Spring, MD)
- 22 days ago
The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned...
- Washington, DC (9 miles from Silver Spring, MD)
- 30+ days ago
- Washington, DC (9 miles from Silver Spring, MD)
- 30+ days ago
Lab Manager, Department of Psychology - Georgetown University College of Arts and Sciences Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus...
Lab Manager, Department of Psychology - Georgetown University College of Arts and Sciences
- Washington, DC (9 miles from Silver Spring, MD)
- 30+ days ago
- Washington, DC (9 miles from Silver Spring, MD)
- 30+ 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...
Demographic Data for Silver Spring, MD
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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in Silver Spring, MD
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Silver Spring, 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
- Quality Systems
- Implementation
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Batch Record Review
- GxP
- ICH GCP
- Assay Development
- Institutional Review Board
- Spectrophotometer
- Cancer Research
- Gene Therapy
- Lab Safety
- Molecular Biology
- ICH Guidelines
- Medical Affairs
- Next-Generation Sequencing
- Clinical Laboratory Operations
- Water Testing
- Biology
- Scientific Research
- Microbiology
- Drug Development
- Pharmacovigilance
- Fermentation
- Immunology
- Medical Writing
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Collections
- Strategy Development
- Quality Control
- Auditing
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Inventory Management
- Interpersonal Skills
- Bachelor's Degree
- Policy Development
- Project Management
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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