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.
Senior Manager, Regulatory Affairs, Advertising & Promotion
- Regeneron Pharmaceuticals
- Sleepy Hollow, NY
- 19 hours ago
- Sleepy Hollow, NY
- 19 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 PersonCertifications: --- Preferred Qualifications Education: A bachelor's degree (or higher) in neuroscience, cognitive science, computer science, psychology, sociology, biology, physics, math, or other...
In PersonTranslational Lab Manager - CICET
- Columbia University In the City of New York
- NY
- 30+ days ago
- NY
- 30+ days ago
Minimum Qualifications Bachelor's degree in Biology, Immunology, Molecular Biology, or related life science discipline....
In PersonMinimum of 1-2 years of relevant laboratory experience supporting correlative studies for cell or gene therapy clinical trials, preferably in immunology-focused research....
In PersonManager, Regulatory Affairs, Advertising & Promotion
- Regeneron Pharmaceuticals
- Sleepy Hollow, NY
- 90+ days ago
- Sleepy Hollow, NY
- 90+ days ago
trial recruitment materials, and familiarity with labeling regulations is desirable Contributes to the influence of cross-functional teams and may interact with senior management #GDRAJobs Does this...
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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
- Continuous Improvement
- Quality Systems
- Quality Management
- Change Control
- 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
- Drug Discovery
- 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
- Written Communication
- Investigation
- Quality Assurance
- Documentation
- Mentoring
- Interpersonal Skills
- Implementation
- Verbal Communication
- Reporting
- Inventory Management
- Policy Development
- Collaboration
- Education Experience
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Leadership
- Communication Skills
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