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.
Associate Manager, Quality Assurance (Visual Inspection)
- East Greenbush, NY
- 2 days ago
- East Greenbush, NY
- 2 days ago
We are currently looking to fill an Associate Manager QA (Visual Inspection) position. This position will be responsible for supervising a team of QA employees and their prospective area(s) and/or...
Lab Manager, Michael Kharas Lab Memorial Sloan-Kettering Cancer Center
- New York, NY
- 4 days ago
- New York, NY
- 4 days ago
We focus on RNA regulators in stem cell biology, aiming to uncover novel therapeutic targets in cancer and regenerative medicine....
We focus on RNA regulators in stem cell biology, aiming to uncover novel therapeutic targets in cancer and regenerative medicine....
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe...
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
If you are a current Barnard College employee, please use the internal career site to apply for this position. Job: Lab Manager - Resetarits Lab Job Summary: The full-time Laboratory Manager will...
If you are a current Barnard College employee, please use the internal career site to apply for this position. Job: Lab Manager - Resetarits Lab Job Summary: The full-time Laboratory Manager will...
If you are a current Barnard College employee, please use the internal career site to apply for this position. Job: Lab Manager Resetarits Lab Job Summary: The full-time Laboratory Manager will...
Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA
- New York, NY
- 21 days ago
- New York, NY
- 21 days ago
About myTomorrows myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options. We strive to enable earlier and better treatment access by...
Associate Manager, Quality Assurance (Visual Inspection)
- New York, NY
- 30+ days ago
- New York, NY
- 30+ days ago
We are currently looking to fill an Associate Manager QA (Visual Inspection) position. This position will be responsible for supervising a team of QA employees and their prospective area(s) and/or...
Director, Regulatory Affairs Business Operations
- Tarrytown, NY
- 30+ days ago
- Tarrytown, NY
- 30+ days ago
This role resides in the Global Development area of Regulatory Affairs, Global Patient Safety and Development Quality (RA, GPS and DQ) and the Director of Strategy Planning and Operations role...
The best thing about this role Are you looking to make a difference by improving the health of our patients? Here you will find an innovative culture that is patient-focused and dedicated to...
Associate Director, Regulatory Affairs - Genetic Medicine & Thrombosis
- Tarrytown, NY
- 60+ days ago
- Tarrytown, NY
- 60+ days ago
The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and...
About the Position: The Research Laboratory Manager supports the Principal Investigator with the execution and maintenance of the research study, and the management of study documentation. The...
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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
- Verbal Communication
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Assay Development
- Biomarkers
- Flow Cytometry
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Next-Generation Sequencing
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Biology
- Stem Cells
- Microbiology
- Biotechnology
- Clinical Trials
- Good Laboratory Practice
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Microsoft Office
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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