Director of Quality Assurance and Regulatory Affairs Jobs in Maryland
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.
Qualifications: BS or BA degree in Biology, Chemistry or other relevant degree. At least 5 years experience in the CRO industry and 3 years supervisory experience or equivalent experience....
Regulatory Affairs Manager Introduction to role The Regulatory Affairs Manager (RAM) is an experienced regulatory specialist with strong project management capabilities responsible for leading the...
Overview Please note that this position is contingent upon the successful award of a contract currently under bid. Goldbelt Professional Services specializes in providing expert resources for...
Under limited supervision, delivers of high quality, cost-effective patient care services and administrative management of Pathology services in the Clinical Laboratory and Point of Care Testing....
Director, Regulatory Affairs - CMC (Cell Therapy)
- Gaithersburg, MD
- 6 days ago
- Gaithersburg, MD
- 6 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...
Overview As a senior member of the quality assurance team, you will work collaboratively with laboratory personnel and groups throughout the organization to ensure compliance with regulatory...
Experimental Mechanics of Materials Test Lab Manager
- Aberdeen Proving Ground, MD
- 60+ days ago
- Aberdeen Proving Ground, MD
- 60+ days ago
Join Us in Making a Difference in the Lives of Those Defending Our Nation! Why SURVICE? Come join the SURVICE Engineering mission to protect, enhance, and enable those who defend the United...
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Director of Quality Assurance and Regulatory Affairss in Maryland 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
- Quality Management
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- TrackWise
- ICH GCP
- Institutional Review Board
- Animal Models
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Molecular Biology
- Lab Safety
- Neurobiology
- Clinical Laboratory Operations
- Proteomics
- Scientific Research
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Medical Writing
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- General Repair
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Interpersonal Skills
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Policy Development
- Bachelor's Degree
- Inventory Management
- Regulations
- Microsoft Office
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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