Director of Quality Assurance and Regulatory Affairs Jobs in Warminster, 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.
- ICON
- Blue Bell, PA (11 miles from Warminster, PA)
- 12 days ago
- Blue Bell, PA (11 miles from Warminster, PA)
- 12 days ago
Director, Regulatory Affairs ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a...
In Person- Jefferson
- Philadelphia, PA (18 miles from Warminster, PA)
- 19 days ago
- Philadelphia, PA (18 miles from Warminster, 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 PersonExecutive Director, Quality Assurance
- Harmony Biosciences Holdings, Inc.
- Plymouth Meeting, PA (12 miles from Warminster, PA)
- 22 days ago
- Plymouth Meeting, PA (12 miles from Warminster, PA)
- 22 days ago
Qualifications: Bachelor of Science required; MS or PhD preferred in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology or related field strongly preferred....
HybridExecutive Director, Regulatory Affairs Office of Promotion and Advertising Review (OPAR)
- Merck Sharp Dohme
- North Wales, PA (9 miles from Warminster, PA)
- 26 days ago
- North Wales, PA (9 miles from Warminster, PA)
- 26 days ago
Strongly preferred to have a science-related degree such as biology, chemistry, nursing, pharmacy, social sciences, or QA/regulatory affairs....
Hybrid- University of Pennsylvania
- Philadelphia, PA (18 miles from Warminster, PA)
- 26 days ago
- Philadelphia, PA (18 miles from Warminster, 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 PersonManager, Quality Assurance Operations
- Catalent
- Princeton, NJ (24 miles from Warminster, PA)
- 30+ days ago
- Princeton, NJ (24 miles from Warminster, PA)
- 30+ days ago
trials and to the market....
In PersonManager Quality Assurance (Food & Beverage Manufacturing)
- Baldwin Richardson Foods
- Pennsauken, NJ (18 miles from Warminster, PA)
- 45+ days ago
- Pennsauken, NJ (18 miles from Warminster, PA)
- 45+ days ago
WHAT YOU WILL NEED TO BE SUCCESSFUL Bachelor’s Degree in Food Science, Microbiology, Biology, or related field....
In PersonAssociate Director, Quality Assurance - Warminster, PA
- FUJIFILM Diosynth Biotechnologies
- Warminster, PA
- 45+ days ago
- Warminster, PA
- 45+ days ago
By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials...
In PersonDirector, Regulatory Affairs - CMC
- ICON
- Blue Bell, PA (11 miles from Warminster, PA)
- 60+ days ago
- Blue Bell, PA (11 miles from Warminster, PA)
- 60+ days ago
Director, Regulatory Affairs - CMC ICON plc is a world-leading healthcare intelligence and clinical research organization. Were proud to foster an inclusive environment driving innovation and...
RemoteDirector, Regulatory Affairs, Ex-US
- Larimar Therapeutics
- Philadelphia, PA (18 miles from Warminster, PA)
- 60+ days ago
- Philadelphia, PA (18 miles from Warminster, PA)
- 60+ days ago
Apply Description Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases...
In PersonAssociate Principal Scientist (Associate Director) - Regulatory Affairs - CMC, Biologics
- Merck Sharp Dohme
- North Wales, PA (9 miles from Warminster, PA)
- 90+ days ago
- North Wales, PA (9 miles from Warminster, 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 (9 miles from Warminster, PA)
- 90+ days ago
- North Wales, PA (9 miles from Warminster, PA)
- 90+ days ago
Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, Chemistry or Biochemistry....
HybridManager, Quality Assurance (GMP)
- Summit Therapeutics Sub, Inc.
- Princeton, NJ (24 miles from Warminster, PA)
- 90+ days ago
- Princeton, NJ (24 miles from Warminster, PA)
- 90+ days ago
Location: On-Site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami FL locations About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused...
In PersonDemographic Data for Warminster, PA
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Director of Quality Assurance and Regulatory Affairss in Warminster, 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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