Director of Quality Assurance and Regulatory Affairs Jobs in Jersey City, 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.
Director, Quality Assurance and Testing
- New York, NY (4 miles from Jersey City, NJ)
- 2 days ago
- New York, NY (4 miles from Jersey City, NJ)
- 2 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...
Regulatory Affairs Director - Oncology
- New York, NY (4 miles from Jersey City, NJ)
- 6 days ago
- New York, NY (4 miles from Jersey City, 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 (23 miles from Jersey City, NJ)
- 8 days ago
- Warren, NJ (23 miles from Jersey City, NJ)
- 8 days ago
Knowledge and experience in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and/or Good Clinical Practice (GCP) regulations....
Senior Manager of Quality Assurance
- Livingston, NJ (13 miles from Jersey City, NJ)
- 8 days ago
- Livingston, NJ (13 miles from Jersey City, NJ)
- 8 days ago
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 (4 miles from Jersey City, NJ)
- 9 days ago
- New York, NY (4 miles from Jersey City, NJ)
- 9 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 (13 miles from Jersey City, NJ)
- 16 days ago
- Rahway, NJ (13 miles from Jersey City, 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...
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 (19 miles from Jersey City, NJ)
- 28 days ago
- Parsippany, NJ (19 miles from Jersey City, 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 (18 miles from Jersey City, NJ)
- 29 days ago
- Madison, NJ (18 miles from Jersey City, 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 (19 miles from Jersey City, NJ)
- 30+ days ago
- Parsippany, NJ (19 miles from Jersey City, 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)...
Senior Manager, Regulatory Affairs Americas
- Morristown, NJ (22 miles from Jersey City, NJ)
- 60+ days ago
- Morristown, NJ (22 miles from Jersey City, 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 Jersey City, NJ
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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in Jersey City, NJ
Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Jersey City, 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
- 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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