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.
This is a full time, 18 month term position (expected to start in July 2025 and last through December 2026) Skills, Qualifications & Requirements: Required Qualifications: Undergraduate degree in biology...
This is a full time, 18 month term position (expected to start in July 2025 and last through December 2026) Skills, Qualifications & Requirements: Required Qualifications: Undergraduate degree in biology...
This is a full time, 18 month term position (expected to start in July 2025 and last through December 2026) Skills, Qualifications & Requirements: Required Qualifications: Undergraduate degree in biology...
Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA
- New York, NY
- 6 days ago
- New York, NY
- 6 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...
More About Recursion Recursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery....
Associate Manager, Quality Assurance (Visual Inspection)
- New York, NY
- 15 days ago
- New York, NY
- 15 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...
Director, Regulatory Affairs Business Operations
- Tarrytown, NY
- 20 days ago
- Tarrytown, NY
- 20 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...
We are seeking a Manager, Quality Assurance - Bioanalytics to join IQVIA Laboratories in Ithaca, NY. We hire passionate innovators who drive healthcare forward through thoughtful and inclusive...
Manager, Regulatory Affairs Strategy - Oncology
- Tarrytown, NY
- 45+ days ago
- Tarrytown, NY
- 45+ days ago
The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel...
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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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
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Flow Cytometry
- Good Clinical Practice
- Real-Time Polymerase Chain Reaction
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Transfection
- Cloning
- Clinical Laboratory Operations
- Cancer Biology
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Drug Development
- Biology
- Pharmacovigilance
- Stem Cells
- Microbiology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Laboratory Management
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Collections
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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