Manager of Quality Assurance and Regulatory Affairs Jobs in New Jersey
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.
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
Executive Director, Regulatory Affairs Strategist
- Bridgewater, NJ
- 5 days ago
- Bridgewater, NJ
- 5 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 Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Trenton, NJ
- 6 days ago
- Trenton, NJ
- 6 days ago
This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure...
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Rahway, NJ
- 6 days ago
- Rahway, NJ
- 6 days ago
Job Description This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to...
Minimum 7-10 years in Regulatory Affairs in an FDA Regulated Industry is required Thorough knowledge of ICH Guidelines and FDA cGMPs and Guidelines is required....
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...
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...
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...
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
Associate Director Quality Assurance Compliance, Hopewell NJ Site
- Pennington, NJ
- 16 days ago
- Pennington, NJ
- 16 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...
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 WorkAbout Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to...
Senior Validation Manager, Quality Assurance (4849)
- Cranbury, NJ
- 30+ days ago
- Cranbury, NJ
- 30+ 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...
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...
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...
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Manager of Quality Assurance and Regulatory Affairss in New Jersey 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
- Electrical Engineering
- Employee Development
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Drug Development
- Biology
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
- Process Development
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Investigation
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Regulations
- Inventory Management
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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