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.
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...
Remote WorkData Integrity Manager - Quality Assurance
- New Brunswick, NJ
- 10 days ago
- New Brunswick, NJ
- 10 days ago
Data Integrity Manager Job Number: 25-04395 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Data Integrity Manager for our client in New Brunswick,...
Senior Validation Manager, Quality Assurance (4849)
- Cranbury, NJ
- 20 days ago
- Cranbury, NJ
- 20 days ago
Job Title - Senior Validation Manager, Quality Assurance Work Location - Cranbury NJ Responsibilites: Manages the QA Validation process at WuXi Biologics BioDEV USA Accountable for QA Review of...
Position Summary The Director of Regulatory Affairs (RA) Labeling will lead the development of a cross-functional labeling strategy for products worldwide, including providing expert input on...
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...
Education: Master Degree (MS/MA) Science degree (Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) - Required Experience: 11 years or more in Regulatory Affairs in biologic...
Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...
Our client is looking to fill the role of Director Quality Control. Salary open $160-175k Responsibilities: Oversee Quality Control functions, ensuring compliance with regulatory standards and...
Executive Director, Regulatory Affairs Strategist
- Bridgewater, NJ
- 28 days ago
- Bridgewater, NJ
- 28 days ago
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees,...
Senior Scientist/Associate Director, Regulatory Affairs CMC
- Basking Ridge, NJ
- 28 days ago
- Basking Ridge, NJ
- 28 days ago
Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...
Position Details Position Information Recruitment/Posting Title Lab Manager - Casual Posting Number 25TM0178 Department Engn - Biomedical Engineering Overview Rutgers, The State University of New...
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees,...
Director, Regulatory Affairs Strategy- Oncology
- Princeton, NJ
- 60+ days ago
- Princeton, NJ
- 60+ days ago
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral;...
Executive Director, Regulatory Affairs
- Princeton Junction, NJ
- 60+ days ago
- Princeton Junction, NJ
- 60+ days ago
Overview of Role: The Vice President, Regulatory Affairs is responsible for developing and overseeing global strategies, RA operations, and global labeling to secure IND/CTA approvals for various...
Senior Director, Regulatory Affairs Global Regulatory Leader
- Princeton Junction, NJ
- 60+ days ago
- Princeton Junction, NJ
- 60+ days ago
Overview of Role: The Senior Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various...
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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
- Mentoring
- Quality Systems
- Implementation
- Quality Management
- Change Control
- Document Management
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Institutional Review Board
- ICH GCP
- Assay Development
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Next-Generation Sequencing
- Polymerase Chain Reaction
- Drug Development
- Biochemistry
- Biology
- Pharmacovigilance
- Immunology
- Medical Writing
- Microbiology
- Microscopy
- Scientific Writing
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Collaboration
- Documentation
- Quality Assurance
- Interpersonal Skills
- Bachelor's Degree
- Education Experience
- Regulations
- Reporting
- Inventory Management
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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