Director of Quality Assurance and Regulatory Affairs Jobs in Nutley, 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.
Regulatory Affairs Director - Oncology
- New York, NY (9 miles from Nutley, NJ)
- 4 hours ago
- New York, NY (9 miles from Nutley, NJ)
- 4 hours 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...
Lab Manager, Michael Kharas Lab Memorial Sloan-Kettering Cancer Center
- New York, NY (9 miles from Nutley, NJ)
- 4 days ago
- New York, NY (9 miles from Nutley, NJ)
- 4 days ago
We focus on RNA regulators in stem cell biology, aiming to uncover novel therapeutic targets in cancer and regenerative medicine....
Lab Manager, Michael Kharas Lab
- New York, NY (9 miles from Nutley, NJ)
- 5 days ago
- New York, NY (9 miles from Nutley, NJ)
- 5 days ago
We focus on RNA regulators in stem cell biology, aiming to uncover novel therapeutic targets in cancer and regenerative medicine....
Director, Regulatory Affairs Strategy
- New York, NY (9 miles from Nutley, NJ)
- 6 days ago
- New York, NY (9 miles from Nutley, NJ)
- 6 days ago
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
- New York, NY (9 miles from Nutley, NJ)
- 22 days ago
- New York, NY (9 miles from Nutley, NJ)
- 22 days ago
If you are a current Barnard College employee, please use the internal career site to apply for this position. Job: Lab Manager Resetarits Lab Job Summary: The full-time Laboratory Manager will...
Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA
- New York, NY (9 miles from Nutley, NJ)
- 22 days ago
- New York, NY (9 miles from Nutley, NJ)
- 22 days ago
About myTomorrows myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options. We strive to enable earlier and better treatment access by...
- Parsippany, NJ (13 miles from Nutley, NJ)
- 27 days ago
- Parsippany, NJ (13 miles from Nutley, NJ)
- 27 days ago
Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across...
Associate Manager, Quality Assurance (Visual Inspection)
- New York, NY (9 miles from Nutley, NJ)
- 30+ days ago
- New York, NY (9 miles from Nutley, NJ)
- 30+ days ago
We are currently looking to fill an Associate Manager QA (Visual Inspection) position. This position will be responsible for supervising a team of QA employees and their prospective area(s) and/or...
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ (13 miles from Nutley, NJ)
- 30+ days ago
- Parsippany, NJ (13 miles from Nutley, NJ)
- 30+ days ago
Gilead Sciences, Inc. Director, Regulatory Affairs Global Labeling in Parsippany , New Jersey At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled...
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisais human health care (hhc) mission. Were a growing...
Director, Regulatory Affairs Business Operations
- Basking Ridge, NJ (23 miles from Nutley, NJ)
- 30+ days ago
- Basking Ridge, NJ (23 miles from Nutley, NJ)
- 30+ days ago
This role resides in the Global Development area of Regulatory Affairs, Global Patient Safety and Development Quality (RA, GPS and DQ) and the Director of Strategy Planning and Operations role...
Director, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (23 miles from Nutley, NJ)
- 45+ days ago
- Basking Ridge, NJ (23 miles from Nutley, NJ)
- 45+ 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...
Senior Manager of Quality Assurance
- Livingston, NJ (9 miles from Nutley, NJ)
- 45+ days ago
- Livingston, NJ (9 miles from Nutley, NJ)
- 45+ 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, Regulatory Affairs - Genetic Medicine & Thrombosis
- Basking Ridge, NJ (23 miles from Nutley, NJ)
- 60+ days ago
- Basking Ridge, NJ (23 miles from Nutley, NJ)
- 60+ 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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Director of Quality Assurance and Regulatory Affairss in Nutley, 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
- Verbal Communication
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Assay Development
- Biomarkers
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Next-Generation Sequencing
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Western Blot
- Biology
- Stem Cells
- Microbiology
- Biotechnology
- Clinical Trials
- Good Laboratory Practice
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Policy Development
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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