Director of Quality Assurance and Regulatory Affairs Jobs in Princeton, NJ
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.
- Dayton, NJ (8 miles from Princeton, NJ)
- 3 days ago
- Dayton, NJ (8 miles from Princeton, NJ)
- 3 days ago
Job Purpose : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that products are...
Director, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (21 miles from Princeton, NJ)
- 7 days ago
- Basking Ridge, NJ (21 miles from Princeton, NJ)
- 7 days ago
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide...
Manager, Quality Assurance - GxP (GVP)- East Coast Candidates Only
- Warren, NJ (19 miles from Princeton, NJ)
- 11 days ago
- Warren, NJ (19 miles from Princeton, NJ)
- 11 days ago
Knowledge and experience in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and/or Good Clinical Practice (GCP) regulations....
Clinical Practice (GCP), and standard operating procedures (SOP)....
Clinical Practice (GCP), and standard operating procedures (SOP)....
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our People...
Manager, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (21 miles from Princeton, NJ)
- 23 days ago
- Basking Ridge, NJ (21 miles from Princeton, NJ)
- 23 days ago
The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel...
- Cranbury, NJ (7 miles from Princeton, NJ)
- 24 days ago
- Cranbury, NJ (7 miles from Princeton, NJ)
- 24 days ago
Overview Work at ROCKET PHARMA and help cure rare diseases! Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood...
Director of Regulatory Affairs
- Newtown, PA (17 miles from Princeton, NJ)
- 25 days ago
- Newtown, PA (17 miles from Princeton, NJ)
- 25 days ago
Director of Regulatory Affairs (Newtown, PA) --Manage and direct regulatory affairs and compliance and serve as principal regulatory contact with the U.S. Food and Drug Administration (FDA) on...
Overview The Behavioral Science for Policy Lab (BSPL), directed by Professor Elke Weber, is an interdisciplinary lab at the intersection of the Andlinger Center for Energy and the Environment, the...
Research Lab Manager US-NJ-Princeton Job ID: 2025-20524 Type: Full-Time # of Openings: 1 Category: Research and Laboratory Overview The Behavioral Science for Policy Lab (BSPL), directed by...
., Chemistry, Biochemistry, Molecular Biology, Biotechnology, Biology, Pharmacy); advanced degree preferred....
Associate Director, Regulatory Affairs - Genetic Medicine & Thrombosis
- Basking Ridge, NJ (21 miles from Princeton, NJ)
- 30+ days ago
- Basking Ridge, NJ (21 miles from Princeton, NJ)
- 30+ days ago
The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and...
Associate Director Quality Assurance Compliance, Hopewell NJ Site
- Hopewell, NJ (6 miles from Princeton, NJ)
- 30+ days ago
- Hopewell, NJ (6 miles from Princeton, NJ)
- 30+ days ago
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals...
Associate Director - Regulatory Affairs - Advertising & Promotion
- Plainsboro, NJ (4 miles from Princeton, NJ)
- 45+ days ago
- Plainsboro, NJ (4 miles from Princeton, NJ)
- 45+ days ago
About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider...
Demographic Data for Princeton, NJ
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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in Princeton, NJ
Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Princeton, NJ 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
- Quality Systems
- Supplier Management
- Implementation
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Institutional Review Board
- Cell Biology
- Assay Development
- Transfection
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Clinical Laboratory Operations
- Cell Culture
- DNA Isolation
- Drug Development
- Biochemistry
- Microbiology
- Biology
- Stem Cells
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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