Manager of Quality Assurance and Regulatory Affairs Jobs in Plainsboro, NJ
A Manager of Quality Assurance and Regulatory Affairs in the biotechnology industry is responsible for ensuring that all products and services meet required standards and regulations. They ensure compliance with local, national, and international regulatory requirements, oversee quality control processes, and manage audits and inspections. This role also involves creating and implementing policies and procedures to enhance product quality, efficiency, and safety. They also play a crucial role in the product development process, advising on regulatory requirements and ensuring that compliance is maintained throughout the lifecycle of a product.
Skills required for this role include excellent attention to detail, strong organizational and leadership skills, and in-depth knowledge of regulatory standards and quality control methods. In addition, they should have excellent problem-solving skills, the ability to work under pressure, and strong communication skills. They should also have a strong understanding of biotechnology principles and processes. Certifications such as Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Regulatory Affairs Certification (RAC) are often required. Prior roles that can lead to a Manager of Quality Assurance and Regulatory Affairs include Quality Assurance Specialist, Regulatory Affairs Associate, and Quality Control Supervisor.
- Dayton, NJ (5 miles from Plainsboro, NJ)
- 20 hours ago
- Dayton, NJ (5 miles from Plainsboro, NJ)
- 20 hours 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 (23 miles from Plainsboro, NJ)
- 4 days ago
- Basking Ridge, NJ (23 miles from Plainsboro, NJ)
- 4 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 (20 miles from Plainsboro, NJ)
- 8 days ago
- Warren, NJ (20 miles from Plainsboro, NJ)
- 8 days ago
Knowledge and experience in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and/or Good Clinical Practice (GCP) regulations....
Sr. Director, Quality Assurance PV
- Princeton, NJ (4 miles from Plainsboro, NJ)
- 14 days ago
- Princeton, NJ (4 miles from Plainsboro, NJ)
- 14 days ago
Clinical Practice (GCP), and standard operating procedures (SOP)....
Director, Quality Assurance (New Modalities)
- Rahway, NJ (24 miles from Plainsboro, NJ)
- 16 days ago
- Rahway, NJ (24 miles from Plainsboro, NJ)
- 16 days ago
Reporting to the AVP of New Modalities our company's Manufacturing Division Quality, this leader is responsible for supporting the implementation of a unique quality oversight model necessary to...
Sr. Director, Quality Assurance
- Princeton, NJ (4 miles from Plainsboro, NJ)
- 19 days ago
- Princeton, NJ (4 miles from Plainsboro, NJ)
- 19 days ago
Clinical Practice (GCP), and standard operating procedures (SOP)....
Manager, Regulatory Affairs Strategy
- Princeton, NJ (4 miles from Plainsboro, NJ)
- 20 days ago
- Princeton, NJ (4 miles from Plainsboro, NJ)
- 20 days ago
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 (23 miles from Plainsboro, NJ)
- 20 days ago
- Basking Ridge, NJ (23 miles from Plainsboro, NJ)
- 20 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 (3 miles from Plainsboro, NJ)
- 21 days ago
- Cranbury, NJ (3 miles from Plainsboro, NJ)
- 21 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 (20 miles from Plainsboro, NJ)
- 22 days ago
- Newtown, PA (20 miles from Plainsboro, NJ)
- 22 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...
- Princeton, NJ (4 miles from Plainsboro, NJ)
- 22 days ago
- Princeton, NJ (4 miles from Plainsboro, NJ)
- 22 days ago
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 Princeton University
- Princeton, NJ (4 miles from Plainsboro, NJ)
- 23 days ago
- Princeton, NJ (4 miles from Plainsboro, NJ)
- 23 days ago
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...
Regulatory Affairs Manager/Sr Manager (GCP)
- Princeton, NJ (4 miles from Plainsboro, NJ)
- 29 days ago
- Princeton, NJ (4 miles from Plainsboro, NJ)
- 29 days ago
Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials Supports Head of Department in business development activities including the preparation of client proposals...
Senior Manager, Regulatory Affairs - Clinical Development
- Princeton, NJ (4 miles from Plainsboro, NJ)
- 29 days ago
- Princeton, NJ (4 miles from Plainsboro, NJ)
- 29 days ago
., Chemistry, Biochemistry, Molecular Biology, Biotechnology, Biology, Pharmacy); advanced degree preferred....
Associate Director, Regulatory Affairs - Genetic Medicine & Thrombosis
- Basking Ridge, NJ (23 miles from Plainsboro, NJ)
- 30+ days ago
- Basking Ridge, NJ (23 miles from Plainsboro, 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...
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Plainsboro, NJ offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Quality Assurance and Regulatory Affairs position
- Quality Systems
- Supplier Management
- Implementation
- Safe Quality Food
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Assay Development
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Drug Discovery
- Polymerase Chain Reaction
- Pharmacovigilance
- Clinical Laboratory Operations
- Cell Culture
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- 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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