Manager of Quality Assurance and Regulatory Affairs Jobs in Livingston, 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.
Director, Quality Assurance and Testing
- New York, NY (17 miles from Livingston, NJ)
- 3 days ago
- New York, NY (17 miles from Livingston, NJ)
- 3 days ago
At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the worlds financial system we touch nearly 20% of the worlds investible...
Director, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (14 miles from Livingston, NJ)
- 4 days ago
- Basking Ridge, NJ (14 miles from Livingston, 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...
Regulatory Affairs Director - Oncology
- New York, NY (17 miles from Livingston, NJ)
- 6 days ago
- New York, NY (17 miles from Livingston, NJ)
- 6 days ago
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About...
Manager, Quality Assurance - GxP (GVP)- East Coast Candidates Only
- Warren, NJ (14 miles from Livingston, NJ)
- 8 days ago
- Warren, NJ (14 miles from Livingston, 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...
Associate Director of Regulatory Affairs
- New York, NY (17 miles from Livingston, NJ)
- 10 days ago
- New York, NY (17 miles from Livingston, NJ)
- 10 days ago
Your work will change lives. Including your own. The Impact You'll Make Recursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential...
Director, Quality Assurance (New Modalities)
- Rahway, NJ (12 miles from Livingston, NJ)
- 16 days ago
- Rahway, NJ (12 miles from Livingston, 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...
Manager, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (14 miles from Livingston, NJ)
- 20 days ago
- Basking Ridge, NJ (14 miles from Livingston, 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...
Senior Director, Regulatory Affairs
- Jersey City, NJ (13 miles from Livingston, NJ)
- 21 days ago
- Jersey City, NJ (13 miles from Livingston, NJ)
- 21 days ago
Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP)....
Senior Director, Regulatory Affairs Advertising &
- Parsippany, NJ (6 miles from Livingston, NJ)
- 28 days ago
- Parsippany, NJ (6 miles from Livingston, 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...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Madison, NJ (5 miles from Livingston, NJ)
- 29 days ago
- Madison, NJ (5 miles from Livingston, NJ)
- 29 days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Senior Director, Regulatory Affairs Advertising & Promotion
- Parsippany, NJ (6 miles from Livingston, NJ)
- 30+ days ago
- Parsippany, NJ (6 miles from Livingston, NJ)
- 30+ days ago
Senior Director, Regulatory Affairs Advertising & Promotion Job ID: 7575 Job Title: Senior Director, Regulatory Affairs Advertising & Promotion Location: Parsippany, NJ Location: (Hybrid)...
Associate Director, Regulatory Affairs - Genetic Medicine & Thrombosis
- Basking Ridge, NJ (14 miles from Livingston, NJ)
- 30+ days ago
- Basking Ridge, NJ (14 miles from Livingston, 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...
Senior Manager, Regulatory Affairs Americas
- Morristown, NJ (8 miles from Livingston, NJ)
- 60+ days ago
- Morristown, NJ (8 miles from Livingston, NJ)
- 60+ days ago
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, theres no magic formula to how we do it. Our greatest scientific solution is talented...
Demographic Data for Livingston, NJ
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Livingston, 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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