Director of Quality Assurance and Regulatory Affairs Jobs in Frederick, 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.
Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution
- Gaithersburg, MD (23 miles from Frederick, MD)
- 19 days ago
- Gaithersburg, MD (23 miles from Frederick, MD)
- 19 days ago
At AstraZeneca's Alexion division, we push boundaries in rare disease biopharma by translating complex biology into transformative medicines....
Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution
- Gaithersburg, MD (23 miles from Frederick, MD)
- 22 days ago
- Gaithersburg, MD (23 miles from Frederick, 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...
Regulatory Affairs Manager V (Regulatory Affairs)
- Fort Detrick, MD (6 miles from Frederick, MD)
- 24 days ago
- Fort Detrick, MD (6 miles from Frederick, MD)
- 24 days ago
FDA regulations, ICH guidelines)....
Quality Assurance Manager (Quality Assurance Analyst)
- Frederick, MD
- 24 days ago
- Frederick, MD
- 24 days ago
Overview Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to...
Quality Assurance Manager (Quality Assurance Analyst) NEW
- Frederick, MD
- 26 days ago
- Frederick, MD
- 26 days ago
Quality Assurance Manager (Quality Assurance Analyst) Goldbelt Inc Today Secret Unspecified Unspecified IT - QA and Test Frederick, MD (ON-SITE/OFFICE) Overview Goldbelt Professional Services...
Demographic Data for Frederick, MD
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Director of Quality Assurance and Regulatory Affairss in Frederick, 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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