Director of Quality Assurance and Regulatory Affairs Jobs in Plymouth Meeting, PA
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.
- Jefferson
- Philadelphia, PA (12 miles from Plymouth Meeting, PA)
- 19 days ago
- Philadelphia, PA (12 miles from Plymouth Meeting, PA)
- 19 days ago
Preferred Qualifications Masters Degree in environmental science, chemistry, biology or a related scientific discipline Physical Demands Lift and carry 40-50 lbs....
In Person- University of Pennsylvania
- Philadelphia, PA (12 miles from Plymouth Meeting, PA)
- 26 days ago
- Philadelphia, PA (12 miles from Plymouth Meeting, PA)
- 26 days ago
Lab Manager, C.R.I.T. University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This...
In PersonDirector, Regulatory Affairs CMC (Biologics, Combination Products)
- Teva Pharmaceutical Industries
- West Chester, PA (19 miles from Plymouth Meeting, PA)
- 45+ days ago
- West Chester, PA (19 miles from Plymouth Meeting, PA)
- 45+ days ago
We Are Teva We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or...
In PersonAssociate Principal Scientist (Associate Director) - Regulatory Affairs - CMC, Biologics
- Merck Sharp Dohme
- North Wales, PA (6 miles from Plymouth Meeting, PA)
- 90+ days ago
- North Wales, PA (6 miles from Plymouth Meeting, PA)
- 90+ days ago
Fields of study include Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry....
HybridPrincipal Scientist (Director) - Regulatory Affairs-CMC
- Merck Sharp Dohme
- North Wales, PA (6 miles from Plymouth Meeting, PA)
- 90+ days ago
- North Wales, PA (6 miles from Plymouth Meeting, PA)
- 90+ days ago
Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, Chemistry or Biochemistry....
HybridDemographic Data for Plymouth Meeting, PA
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Plymouth Meeting, PA 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
- Continuous Improvement
- Quality Systems
- Quality Management
- Change Control
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Molecular Biology
- ICH Guidelines
- Institutional Review Board
- ICH GCP
- Drug Development
- Clinical Laboratory Operations
- Medical Affairs
- Lab Safety
- Tissue Culture
- Gene Therapy
- Pharmacovigilance
- Biochemistry
- Microbiology
- Biology
- Immunology
- Good Laboratory Practice
- Clinical Trials
- Autoclave
- Lab Experience
- Clinical Research
- Biotechnology
- Laboratory Management
- Equipment Calibration
- Neuroscience
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Strategy Development
- Engineering
- Auditing
- Investigation
- Quality Assurance
- Documentation
- Mentoring
- Interpersonal Skills
- Implementation
- Verbal Communication
- Reporting
- Inventory Management
- Policy Development
- Collaboration
- Education Experience
- Bachelor's Degree
- Regulations
- Research Skills
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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