Director of Quality Assurance and Regulatory Affairs Jobs in Hopewell, NJ
Data Integrity Manager - Quality Assurance
- New Brunswick, NJ (18 miles from Hopewell, NJ)
- 4 days ago
- New Brunswick, NJ (18 miles from Hopewell, NJ)
- 4 days ago
Data Integrity Manager Job Number: 25-04395 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Data Integrity Manager for our client in New Brunswick,...
Senior Validation Manager, Quality Assurance (4849)
- Cranbury, NJ (14 miles from Hopewell, NJ)
- 14 days ago
- Cranbury, NJ (14 miles from Hopewell, NJ)
- 14 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)
- 15 days ago
- Princeton, NJ (6 miles from Hopewell, NJ)
- 15 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)
- 16 days ago
- Cranbury, NJ (14 miles from Hopewell, NJ)
- 16 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...
Associate Director Regulatory Affairs
- Piscataway, NJ (19 miles from Hopewell, NJ)
- 16 days ago
- Piscataway, NJ (19 miles from Hopewell, NJ)
- 16 days ago
Education: Master Degree (MS/MA) Science degree (Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) - Required Experience: 11 years or more in Regulatory Affairs in biologic...
- Princeton, NJ (6 miles from Hopewell, NJ)
- 22 days ago
- Princeton, NJ (6 miles from Hopewell, NJ)
- 22 days ago
Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials Supports Head of Department in business development activities including the preparation of client proposals...
Executive Director, Regulatory Affairs Strategist
- Bridgewater, NJ (15 miles from Hopewell, NJ)
- 22 days ago
- Bridgewater, NJ (15 miles from Hopewell, NJ)
- 22 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,...
Senior Scientist/Associate Director, Regulatory Affairs CMC
- Basking Ridge, NJ (21 miles from Hopewell, NJ)
- 22 days ago
- Basking Ridge, NJ (21 miles from Hopewell, NJ)
- 22 days ago
Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...
Manager, Regulatory Affairs - Project Management
- Bridgewater, NJ (15 miles from Hopewell, NJ)
- 25 days ago
- Bridgewater, NJ (15 miles from Hopewell, NJ)
- 25 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,...
- New Brunswick, NJ (18 miles from Hopewell, NJ)
- 28 days ago
- New Brunswick, NJ (18 miles from Hopewell, NJ)
- 28 days ago
ELISA, Western blot, RNA / DNA quantification), histology, and other experiments under the guidance of the principal investigator. Drafts protocols and manuscripts, where appropriate....
- Piscataway, NJ (19 miles from Hopewell, NJ)
- 28 days ago
- Piscataway, NJ (19 miles from Hopewell, NJ)
- 28 days ago
ELISA, Western blot, RNA/DNA quantification), histology, and other experiments under the guidance of the principal investigator. Drafts protocols and manuscripts, where appropriate....
- Bridgewater, NJ (15 miles from Hopewell, NJ)
- 30+ days ago
- Bridgewater, NJ (15 miles from Hopewell, NJ)
- 30+ 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,...
Director, Regulatory Affairs Strategy- Oncology
- Princeton, NJ (6 miles from Hopewell, NJ)
- 45+ days ago
- Princeton, NJ (6 miles from Hopewell, NJ)
- 45+ days ago
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral;...
Executive Director, Regulatory Affairs
- Princeton Junction, NJ (12 miles from Hopewell, NJ)
- 60+ days ago
- Princeton Junction, NJ (12 miles from Hopewell, NJ)
- 60+ days ago
Overview of Role: The Vice President, Regulatory Affairs is responsible for developing and overseeing global strategies, RA operations, and global labeling to secure IND/CTA approvals for various...
Senior Director, Regulatory Affairs Global Regulatory Leader
- Princeton Junction, NJ (12 miles from Hopewell, NJ)
- 60+ days ago
- Princeton Junction, NJ (12 miles from Hopewell, NJ)
- 60+ days ago
Overview of Role: The Senior Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various...
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Director 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 Director of Quality Assurance and Regulatory Affairs position
- ICH GCP
- Gene Therapy
- Supplier Auditing
- Next-Generation Sequencing
- Medical Affairs
- Internal Audits
- Institutional Review Board
- Batch Record Review
- Pharmacovigilance
- TrackWise
- Clinical Laboratory Operations
- Assay Development
- Lab Safety
- ICH Guidelines
- Drug Development
- Immunology
- GxP
- Western Blot
- Change Control
- Scientific Writing
- Quality Management Systems
- Quality Systems
- Good Laboratory Practice
- Polymerase Chain Reaction
- Biochemistry
- Molecular Biology
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- Medical Device Sales
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- Biology
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- Inspections
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- FDA Regulations
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- Standard Operating Procedures
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- Strategy Development
- Engineering
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- Written Communication
- Verbal Communication
- Quality Control
- Auditing
- Collaboration
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- Interpersonal Skills
- Mentoring
- Documentation
- Quality Assurance
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- Education Experience
- Bachelor's Degree
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- Microsoft Office
- Policy Development
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- Teamwork
- Staff Supervision
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- Scheduling
- Leadership
- Communication Skills
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