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.
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
Associate Manager, Quality Assurance (Visual Inspection)
- East Greenbush, NY
- 3 days ago
- East Greenbush, NY
- 3 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...
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....
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...
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...
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 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
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- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
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- Medical Device Sales
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- Good Manufacturing Practices
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
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- Diagnostic
- Masters In Education
- Engineering
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- Auditing
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Regulations
- Inventory Management
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- Research Skills
- Staff Supervision
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