Manager of Quality Assurance and Regulatory Affairs Jobs in Wayne, NJ
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, Regulatory Affairs
- New York City, NY (20 miles from Wayne, NJ)
- 4 days ago
- New York City, NY (20 miles from Wayne, NJ)
- 4 days ago
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 (23 miles from Wayne, NJ)
- 9 days ago
- Rahway, NJ (23 miles from Wayne, NJ)
- 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...
Senior Manager, Regulatory Affairs Advertising & Promotion
- Sleepy Hollow, NY (22 miles from Wayne, NJ)
- 10 days ago
- Sleepy Hollow, NY (22 miles from Wayne, NJ)
- 10 days ago
trial recruitment materials, and familiarity with labeling regulations is desirable Ability to influence cross-functional teams and interact with senior management To be considered for this opportunity...
Research Lab Manager (Assistant Research Scientist) New York University
- New York, NY (18 miles from Wayne, NJ)
- 10 days ago
- New York, NY (18 miles from Wayne, NJ)
- 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 (18 miles from Wayne, NJ)
- 10 days ago
- New York, NY (18 miles from Wayne, NJ)
- 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 (18 miles from Wayne, NJ)
- 11 days ago
- New York, NY (18 miles from Wayne, NJ)
- 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 (8 miles from Wayne, NJ)
- 25 days ago
- Allendale, NJ (8 miles from Wayne, NJ)
- 25 days ago
MS or PhD in chemistry or biology and/or Regulatory Affairs is strongly preferred....
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...
Demographic Data for Wayne, NJ
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Required or preferred licenses and certifications for Manager of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Wayne, NJ 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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