Manager of Quality Assurance and Regulatory Affairs Jobs in New Jersey
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.
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
- 4 days ago
- Basking Ridge, 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
- 8 days ago
- Warren, NJ
- 8 days ago
Knowledge and experience in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and/or Good Clinical Practice (GCP) regulations....
Company: Kelly Services Location: Livingston, NJ Career Level: Mid-Senior Level Industries: Recruitment Agency, Staffing, Job Board Description Kelly Science is seeking a Senior Manager of Quality...
Clinical Practice (GCP), and standard operating procedures (SOP)....
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...
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
- 20 days ago
- Basking Ridge, 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...
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...
Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP)....
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...
Senior Director, Regulatory Affairs Advertising &
- Parsippany, NJ
- 28 days ago
- Parsippany, NJ
- 28 days ago
at PACIRA PHARMACEUTICALS INC in Parsippany, New Jersey, United States Job Description Overview About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and...
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...
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in New Jersey 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
- English
- Quality Systems
- Supplier Management
- Distribution
- Implementation
- Resolution
- Safe Quality Food
- Coaching
- Interpersonal Skills
- 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
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Troubleshooting
- Quality Control
- Investigation
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Inventory Management
- Regulations
- Teaching
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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