Director of Quality Assurance and Regulatory Affairs Jobs in Parsippany, 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.
Senior Manager, Regulatory Affairs, Advertising & Promotion
- Regeneron Pharmaceuticals, Inc.
- Warren, NJ (16 miles from Parsippany, NJ)
- 18 hours ago
- Warren, NJ (16 miles from Parsippany, NJ)
- 18 hours ago
trial recruitment materials, and familiarity with labeling regulations is desirable Ability to influence cross-functional teams and interact with senior management #GDRAJobs Does this sound like you...
In PersonLab Manager, Global MSAT Automation
- Legend Biotech US
- Franklin, NJ (20 miles from Parsippany, NJ)
- 19 days ago
- Franklin, NJ (20 miles from Parsippany, NJ)
- 19 days ago
Requirements Bachelor's degree in biology, Biotechnology, Biochemistry, or a related scientific field (master's preferred). 2+ years of hands-on experience in cell therapy manufacturing or GMP biologics...
In Person- Recordati
- Bridgewater, NJ (21 miles from Parsippany, NJ)
- 30+ days ago
- Bridgewater, NJ (21 miles from Parsippany, NJ)
- 30+ days ago
This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati. Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing...
In PersonTranslational Lab Manager - CICET
- HERC
- New York, NY (22 miles from Parsippany, NJ)
- 30+ days ago
- New York, NY (22 miles from Parsippany, NJ)
- 30+ days ago
Minimum of 1-2 years of relevant laboratory experience supporting correlative studies for cell or gene therapy clinical trials, preferably in immunology-focused research....
In PersonDemographic Data for Parsippany, NJ
Moving to Parsippany, NJ? Find some basic demographic data about Parsippany, NJ below.
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Director of Quality Assurance and Regulatory Affairss in Parsippany, 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
- Continuous Improvement
- Quality Systems
- Quality Management
- Change Control
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Molecular Biology
- ICH Guidelines
- Institutional Review Board
- ICH GCP
- Drug Development
- Clinical Laboratory Operations
- Medical Affairs
- Lab Safety
- Tissue Culture
- Gene Therapy
- Pharmacovigilance
- Biochemistry
- Microbiology
- Biology
- Immunology
- Good Laboratory Practice
- Clinical Trials
- Autoclave
- Lab Experience
- Clinical Research
- Biotechnology
- Laboratory Management
- Equipment Calibration
- Neuroscience
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Strategy Development
- Engineering
- Auditing
- Investigation
- Quality Assurance
- Documentation
- Mentoring
- Interpersonal Skills
- Implementation
- Verbal Communication
- Reporting
- Inventory Management
- Policy Development
- Collaboration
- Education Experience
- Bachelor's Degree
- Regulations
- Research Skills
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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