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.
Associate Director, Regulatory Affairs
- Jersey City, NJ (4 miles from New York, NY)
- 3 days ago
- Jersey City, NJ (4 miles from New York, NY)
- 3 days ago
Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with Good Clinical Practices (GCP), and General Data Protection Regulation (GDPR)....
Associate Director, Regulatory Affairs
- Elmwood Park, NJ (12 miles from New York, NY)
- 4 days ago
- Elmwood Park, NJ (12 miles from New York, NY)
- 4 days ago
Read and understand current FDA guidance(s) and trends, USP general/specific DS/DP monographs, and be familiar with ICH guidelines and post-approval change guidance(s) accordingly....
Senior Manager/Associate Director, Regulatory Affairs - GDP
- Florham Park, NJ (21 miles from New York, NY)
- 5 days ago
- Florham Park, NJ (21 miles from New York, NY)
- 5 days ago
Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines. Excellent communication and interpersonal skills....
Director, Regulatory Affairs-- Therapeutic Area Business Manager
- Parsippany, NJ (22 miles from New York, NY)
- 6 days ago
- Parsippany, NJ (22 miles from New York, NY)
- 6 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...
- Parsippany, NJ (22 miles from New York, NY)
- 6 days ago
- Parsippany, NJ (22 miles from New York, NY)
- 6 days ago
As a privately- owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate...
Senior Manager, Regulatory Affairs
- Parsippany, NJ (22 miles from New York, NY)
- 6 days ago
- Parsippany, NJ (22 miles from New York, NY)
- 6 days ago
Overview About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners...
- Franklin Lakes, NJ (21 miles from New York, NY)
- 15 days ago
- Franklin Lakes, NJ (21 miles from New York, NY)
- 15 days ago
Qualifications: Bachelors degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field and a m inimum of nine years of experience, or equivalent combination...
Regulatory Affairs Manager New York City
- New York City, NY (2 miles from New York, NY)
- 18 days ago
- New York City, NY (2 miles from New York, NY)
- 18 days ago
Qualifications and Skills: Bachelor's degree in life sciences, public health, chemistry, biology, engineering, or other related field....
Regeneron is hiring a Manager, Quality Assurance, to join our team specializing in QA Oversight of our external bulk operations. In this role, you will ensure processes maintain compliance with...
Associate Director/Director, Regulatory Affairs -GDP Contractor
- Florham Park, NJ (21 miles from New York, NY)
- 25 days ago
- Florham Park, NJ (21 miles from New York, NY)
- 25 days ago
Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines. Excellent communication and interpersonal skills....
Senior Manager, Regulatory Affairs Advertising & Promotion
- Sleepy Hollow, NY (24 miles from New York, NY)
- 45+ days ago
- Sleepy Hollow, NY (24 miles from New York, NY)
- 45+ days ago
The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and...
Demographic Data for New York, NY
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Highest Education Level
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
- Quality Systems
- Implementation
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Batch Record Review
- GxP
- ICH GCP
- Assay Development
- Institutional Review Board
- Spectrophotometer
- Cancer Research
- Gene Therapy
- Lab Safety
- Molecular Biology
- ICH Guidelines
- Medical Affairs
- Next-Generation Sequencing
- Clinical Laboratory Operations
- Water Testing
- Biology
- Scientific Research
- Microbiology
- Drug Development
- Pharmacovigilance
- Fermentation
- Immunology
- Medical Writing
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Collections
- Strategy Development
- Quality Control
- Auditing
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Inventory Management
- Interpersonal Skills
- Bachelor's Degree
- Policy Development
- Project Management
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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