Manager of Quality Assurance and Regulatory Affairs Jobs in Hopewell, 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.
- Trenton, NJ (13 miles from Hopewell, NJ)
- 9 days ago
- Trenton, NJ (13 miles from Hopewell, 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...
- Princeton, NJ (6 miles from Hopewell, NJ)
- 11 days ago
- Princeton, NJ (6 miles from Hopewell, NJ)
- 11 days ago
Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting....
Executive Director, Regulatory Affairs Strategist
- Bridgewater, NJ (15 miles from Hopewell, NJ)
- 19 days ago
- Bridgewater, NJ (15 miles from Hopewell, NJ)
- 19 days ago
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees,...
Associate Director, Regulatory Affairs
- Trenton, NJ (13 miles from Hopewell, NJ)
- 28 days ago
- Trenton, NJ (13 miles from Hopewell, NJ)
- 28 days ago
California, US residents click here (. **The job details are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit...
- Trenton, NJ (13 miles from Hopewell, NJ)
- 29 days ago
- Trenton, NJ (13 miles from Hopewell, NJ)
- 29 days ago
We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, were all a part of something bigger than...
Associate Director Quality Assurance Compliance, Hopewell NJ Site
- Pennington, NJ (5 miles from Hopewell, NJ)
- 29 days ago
- Pennington, NJ (5 miles from Hopewell, NJ)
- 29 days ago
**_Core Competencies, Knowledge, and Skill Requirements_** + Scientific degree (ideally chemistry, biology, biotechnology, pharmaceutical sciences or related). + Minimum of 8 years of experience in...
Regulatory Affairs Manager/Sr (Remote)
- Princeton, NJ (6 miles from Hopewell, NJ)
- 30+ days ago
- Princeton, NJ (6 miles from Hopewell, NJ)
- 30+ days ago
trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials Supports Head of Department in business development activities including...
Remote WorkSenior Validation Manager, Quality Assurance (4849)
- Cranbury, NJ (14 miles from Hopewell, NJ)
- 45+ days ago
- Cranbury, NJ (14 miles from Hopewell, NJ)
- 45+ days ago
Job Title - Senior Validation Manager, Quality Assurance Work Location - Cranbury NJ Responsibilites: Manages the QA Validation process at WuXi Biologics BioDEV USA Accountable for QA Review of...
Director Regulatory Affairs Labeling
- Princeton, NJ (6 miles from Hopewell, NJ)
- 45+ days ago
- Princeton, NJ (6 miles from Hopewell, NJ)
- 45+ days ago
Position Summary The Director of Regulatory Affairs (RA) Labeling will lead the development of a cross-functional labeling strategy for products worldwide, including providing expert input on...
Training Manager, Quality Assurance
- Cranbury, NJ (14 miles from Hopewell, NJ)
- 45+ days ago
- Cranbury, NJ (14 miles from Hopewell, NJ)
- 45+ days ago
Overview Work at ROCKET PHARMA and help cure rare diseases! Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood...
Senior Scientist/Associate Director, Regulatory Affairs CMC
- Basking Ridge, NJ (21 miles from Hopewell, NJ)
- 45+ days ago
- Basking Ridge, NJ (21 miles from Hopewell, NJ)
- 45+ days ago
This position develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (e.g., IND, IMPD, IB) and...
- Bridgewater, NJ (15 miles from Hopewell, NJ)
- 60+ days ago
- Bridgewater, NJ (15 miles from Hopewell, NJ)
- 60+ days ago
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees,...
Associate Director Quality Assurance Compliance, Hopewell NJ Site
- Hopewell, NJ
- 90+ days ago
- Hopewell, NJ
- 90+ days ago
Core Competencies, Knowledge, and Skill Requirements Scientific degree (ideally chemistry, biology, biotechnology, pharmaceutical sciences or related)....
Demographic Data for Hopewell, NJ
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Hopewell, 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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