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.
Senior Manager (Director), Regulatory Affairs & Pharmacovigilance
- New York, NY
- 5 hours ago
- New York, NY
- 5 hours ago
Revolutionizing access to medical treatments We're on a mission to enable earlier and better access to treatments and improve the lives of patients. Making it possible for anyone to find and...
The Senior Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on clinical regulatory issues and filings...
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...
Your work will change lives. Including your own. The Impact You'll Make Recursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential...
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...
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...
Job Type Full-time Description TITLE: Assistant Lab Manager REPORTING TO: Lab Manager LOCATION: Walton, NY Lactalis Heritage Dairy is currently seeking candidates to join our team in Walton, NY....
Associate Director, Regulatory Affairs - Genetic Medicine & Thrombosis
- Tarrytown, NY
- 30+ days ago
- Tarrytown, NY
- 30+ 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...
safety, test methods, measurement accuracy Effective communication skills, with the ability to delegate, hold others accountable and interact with all levels of management Proficient in the use of...
Demographic Data for New York
Moving to New York? Find some basic demographic data about New York below.
Manager of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job titles
Salary for Manager of Quality Assurance and Regulatory Affairs Jobs in New York
Highest Education Level
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
- Quality Systems
- Supplier Management
- Implementation
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Institutional Review Board
- Cell Biology
- Assay Development
- Transfection
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Clinical Laboratory Operations
- Cell Culture
- DNA Isolation
- Drug Development
- Biochemistry
- Microbiology
- Biology
- Stem Cells
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Manager of Quality Assurance and Regulatory Affairs Related Career Advice Articles
4 Biotech Opportunities & Career Paths With High Growth Potential
Biotechnology is an emerging segment of the employment market with opportunities spanning healthcare, biopharmaceuticals, agriculture, industry, and academia. If you have a thirst for innovation, this career path might be right for you!
Read article »