Manager of Quality Assurance and Regulatory Affairs Jobs in New York City, NY
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.
- Avenel, NJ (16 miles from New York City, NY)
- 2 days ago
- Avenel, NJ (16 miles from New York City, NY)
- 2 days ago
An established company in the flavor and fragrance industry is seeking an experienced Laboratory Manager to lead its Essential Oils Division. This role focuses on the development and production of...
Company Overview: Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protaras portfolio...
- Rahway, NJ (16 miles from New York City, NY)
- 9 days ago
- Rahway, NJ (16 miles from New York City, NY)
- 9 days ago
The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients...
Research Lab Manager (Assistant Research Scientist) New York University
- New York, NY (2 miles from New York City, NY)
- 10 days ago
- New York, NY (2 miles from New York City, NY)
- 10 days ago
The Jameel Arts and Health Lab (the Lab) seeks a full-time Research Lab Manager to begin early Spring 2025. The Lab was established by the Steinhardt School at New York University, WHO Europe,...
Research Lab Manager (Assistant Research Scientist)
- New York, NY (2 miles from New York City, NY)
- 10 days ago
- New York, NY (2 miles from New York City, NY)
- 10 days ago
The Jameel Arts and Health Lab (the Lab) seeks a full-time Research Lab Manager to begin early Spring 2025. The Lab was established by the Steinhardt School at New York University, WHO Europe,...
Research Lab Manager, Immuno-Oncology
- New York, NY (2 miles from New York City, NY)
- 11 days ago
- New York, NY (2 miles from New York City, NY)
- 11 days ago
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...
- Allendale, NJ (23 miles from New York City, NY)
- 25 days ago
- Allendale, NJ (23 miles from New York City, NY)
- 25 days ago
MS or PhD in chemistry or biology and/or Regulatory Affairs is strongly preferred....
Senior Director Quality & Regulatory Compliance
- Wayne, NJ (20 miles from New York City, NY)
- 29 days ago
- Wayne, NJ (20 miles from New York City, NY)
- 29 days ago
Company Name: Datascope Corp.Job Location: 45 Barbour Pond Drive, Wayne, NJ 07470. Employer will allow remote/telecommuting throughout the U.S.Job title: Senior Director Quality & Regulatory...
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in New York City, NY 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
- Continuous Improvement
- Affirmative Action
- Quality Systems
- Implementation
- Quality Management
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- TrackWise
- Institutional Review Board
- ICH GCP
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Neurobiology
- Clinical Laboratory Operations
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Experimental Design
- Biotechnology
- Scientific Writing
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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