Manager of Quality Assurance and Regulatory Affairs Jobs in New York
A Manager of Quality Assurance and Regulatory Affairs in the biotechnology industry is responsible for ensuring that all products and services meet required standards and regulations. They ensure compliance with local, national, and international regulatory requirements, oversee quality control processes, and manage audits and inspections. This role also involves creating and implementing policies and procedures to enhance product quality, efficiency, and safety. They also play a crucial role in the product development process, advising on regulatory requirements and ensuring that compliance is maintained throughout the lifecycle of a product.
Skills required for this role include excellent attention to detail, strong organizational and leadership skills, and in-depth knowledge of regulatory standards and quality control methods. In addition, they should have excellent problem-solving skills, the ability to work under pressure, and strong communication skills. They should also have a strong understanding of biotechnology principles and processes. Certifications such as Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Regulatory Affairs Certification (RAC) are often required. Prior roles that can lead to a Manager of Quality Assurance and Regulatory Affairs include Quality Assurance Specialist, Regulatory Affairs Associate, and Quality Control Supervisor.
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...
CAH- Laboratory– Lab Manager-Full Time- Day Shift- 8a-4:30p- Req #8539 Pay Range: $46.28-$61.33*+ Responsible for planning, organizing and managing activities within the Laboratory under the...
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About...
Associate Manager, Quality Assurance (Visual Inspection)
- East Greenbush, NY
- 10 days ago
- East Greenbush, NY
- 10 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
- 12 days ago
- New York, NY
- 12 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...
Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA
- New York, NY
- 29 days ago
- New York, NY
- 29 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
- 90+ days ago
- Tarrytown, NY
- 90+ 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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Manager 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 Manager of Quality Assurance and Regulatory Affairs position
- Verbal Communication
- Mentoring
- Quality Systems
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- Institutional Review Board
- Assay Development
- Biomarkers
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Genotyping
- Cell Culture
- Molecular Biology
- Cloning
- Polymerase Chain Reaction
- Cancer Biology
- DNA Isolation
- Drug Development
- Biology
- Pharmacovigilance
- Stem Cells
- Microbiology
- Clinical Trials
- Good Laboratory Practice
- Biotechnology
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Medical Terminology
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Regulations
- Policy Development
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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