Director of Quality Assurance and Regulatory Affairs Jobs in New York, NY
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 New York, NY)
- 2 days ago
- Rahway, NJ (17 miles from New York, NY)
- 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...
Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA
- New York, NY
- 5 days ago
- New York, NY
- 5 days ago
Our services include clinical trial patient recruitment, Expanded Access Program management and Real-World Data collection....
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Rahway, NJ (17 miles from New York, NY)
- 6 days ago
- Rahway, NJ (17 miles from New York, NY)
- 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...
biology, immunology, and animal model research Excellent organizational, analytical, and problem-solving abilities Proficiency in lab management systems and Microsoft Office Suite Knowledge of regulatory...
- Allendale, NJ (20 miles from New York, NY)
- 12 days ago
- Allendale, NJ (20 miles from New York, NY)
- 12 days ago
Minimum 7-10 years in Regulatory Affairs in an FDA Regulated Industry is required Thorough knowledge of ICH Guidelines and FDA cGMPs and Guidelines is required....
Senior Director Quality & Regulatory Compliance
- Wayne, NJ (18 miles from New York, NY)
- 16 days ago
- Wayne, NJ (18 miles from New York, NY)
- 16 days ago
Company Name: Datascope Corp.Job Location: 45 Barbour Pond Drive, Wayne, NJ 07470. Employer will allow remote/telecommuting throughout the U.S.Job title: Senior Director Quality & Regulatory...
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ (22 miles from New York, NY)
- 17 days ago
- Parsippany, NJ (22 miles from New York, NY)
- 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...
Company Overview: Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara's portfolio...
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Director of Quality Assurance and Regulatory Affairss in New York, NY 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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