Director of Quality Assurance and Regulatory Affairs Jobs in New York
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.
Company Overview: Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protaras portfolio...
Laboratory Manager / Lab Manager (No Bench Work)
- Middleport, NY
- 6 days ago
- Middleport, NY
- 6 days ago
Laboratory Manager Location: 45 minutes North of Buffalo, New York Employment Type: Full-time Relocation Assistance: Available Retention Bonus: Up to $20,000 paid every 6 months over 3 years Key...
Senior Manager, Regulatory Affairs Advertising & Promotion
- Sleepy Hollow, NY
- 12 days ago
- Sleepy Hollow, NY
- 12 days ago
trial recruitment materials, and familiarity with labeling regulations is desirable Ability to influence cross-functional teams and interact with senior management To be considered for this opportunity...
Research Lab Manager (Assistant Research Scientist) New York University
- New York, NY
- 12 days ago
- New York, NY
- 12 days ago
The Jameel Arts and Health Lab (the Lab) seeks a full-time Research Lab Manager to begin early Spring 2025. The Lab was established by the Steinhardt School at New York University, WHO Europe,...
Research Lab Manager (Assistant Research Scientist)
- New York, NY
- 12 days ago
- New York, NY
- 12 days ago
The Jameel Arts and Health Lab (the Lab) seeks a full-time Research Lab Manager to begin early Spring 2025. The Lab was established by the Steinhardt School at New York University, WHO Europe,...
Associate Manager, Quality Assurance (Visual Inspection)
- East Greenbush, NY
- 18 days ago
- East Greenbush, NY
- 18 days ago
to remove jewelry, make-up and nail adornments when wearing cleanroom attire To be considered for this role you must hold a BA / BS degree in a life sciences discipline or related field (chemistry, biology...
JOB TITLE: Laboratory Manager DEPARTMENT: Pathology/Clinical Laboratory STATUS: Full-time, Exempt REPORTS TO: Practice Director POSITION SUMMARY: The Laboratory Manager is responsible for the...
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Required or preferred licenses and certifications for Director of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
Director of Quality Assurance and Regulatory Affairss in New York 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
- Continuous Improvement
- Affirmative Action
- Quality Systems
- Implementation
- Quality Management
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- ICH GCP
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Neurobiology
- Clinical Laboratory Operations
- Scientific Research
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Medical Writing
- Immunohistochemistry
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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