Director of Quality Assurance and Regulatory Affairs Jobs in Bridgewater, 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.
Principal Scientist (Director) - Regulatory Affairs-CMC
- Rahway, NJ (17 miles from Bridgewater, NJ)
- 2 days ago
- Rahway, NJ (17 miles from Bridgewater, NJ)
- 2 days ago
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
Executive Director, Regulatory Affairs Strategist
- Bridgewater, NJ
- 6 days ago
- Bridgewater, NJ
- 6 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,...
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Rahway, NJ (17 miles from Bridgewater, NJ)
- 6 days ago
- Rahway, NJ (17 miles from Bridgewater, NJ)
- 6 days ago
Job Description This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to...
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ (21 miles from Bridgewater, NJ)
- 17 days ago
- Parsippany, NJ (21 miles from Bridgewater, NJ)
- 17 days ago
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
Associate Director Quality Assurance Compliance, Hopewell NJ Site
- Pennington, NJ (20 miles from Bridgewater, NJ)
- 17 days ago
- Pennington, NJ (20 miles from Bridgewater, NJ)
- 17 days ago
**_Core Competencies, Knowledge, and Skill Requirements_** + Scientific degree (ideally chemistry, biology, biotechnology, pharmaceutical sciences or related). + Minimum of 8 years of experience in...
Regulatory Affairs Manager/Sr (Remote)
- Princeton, NJ (15 miles from Bridgewater, NJ)
- 18 days ago
- Princeton, NJ (15 miles from Bridgewater, NJ)
- 18 days ago
trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials Supports Head of Department in business development activities including...
Remote WorkManager Regulatory Affairs Operations
- Princeton, NJ (15 miles from Bridgewater, NJ)
- 21 days ago
- Princeton, NJ (15 miles from Bridgewater, NJ)
- 21 days ago
About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to...
Senior Validation Manager, Quality Assurance (4849)
- Cranbury, NJ (19 miles from Bridgewater, NJ)
- 30+ days ago
- Cranbury, NJ (19 miles from Bridgewater, NJ)
- 30+ 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...
Director Regulatory Affairs Labeling
- Princeton, NJ (15 miles from Bridgewater, NJ)
- 30+ days ago
- Princeton, NJ (15 miles from Bridgewater, NJ)
- 30+ days ago
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...
Training Manager, Quality Assurance
- Cranbury, NJ (19 miles from Bridgewater, NJ)
- 30+ days ago
- Cranbury, NJ (19 miles from Bridgewater, NJ)
- 30+ days ago
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...
Senior Scientist/Associate Director, Regulatory Affairs CMC
- Basking Ridge, NJ (6 miles from Bridgewater, NJ)
- 45+ days ago
- Basking Ridge, NJ (6 miles from Bridgewater, NJ)
- 45+ days ago
This position develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (e.g., IND, IMPD, IB) and...
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,...
Associate Director Quality Assurance Compliance, Hopewell NJ Site
- Hopewell, NJ (15 miles from Bridgewater, NJ)
- 90+ days ago
- Hopewell, NJ (15 miles from Bridgewater, NJ)
- 90+ days ago
Core Competencies, Knowledge, and Skill Requirements Scientific degree (ideally chemistry, biology, biotechnology, pharmaceutical sciences or related)....
Demographic Data for Bridgewater, NJ
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Director of Quality Assurance and Regulatory Affairss in Bridgewater, 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
- Mentoring
- Electrical Engineering
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Drug Development
- Biology
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Research and Development
- Process Development
- Diagnostic
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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