Director of Quality Assurance and Regulatory Affairs Jobs in Dayton, NJ
A Director of Quality Assurance and Regulatory Affairs in the biotechnology industry is essentially responsible for developing and implementing systems that ensure products meet quality standards and regulatory requirements. This includes conducting internal audits, leading investigations into quality issues, liaising with regulatory bodies, and overseeing the submission of regulatory documents. They are also responsible for ensuring compliance with regulatory requirements and standards such as ISO, FDA, and EMEA. They play a crucial role in maintaining the company's reputation and ensuring customer satisfaction by ensuring that products are safe, reliable, and meet both customer and regulatory requirements.
Key skills for this role include strong analytical and problem-solving skills, excellent communication skills, and a strong knowledge of the biotechnology industry and its associated regulations. They should also have strong leadership skills, as they will often be leading teams and coordinating with other departments. Important certifications may include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC), or Certified Quality Manager (CQM). Prior to becoming a Director of Quality Assurance and Regulatory Affairs, an individual may have roles such as Quality Assurance Manager, Regulatory Affairs Specialist, or Senior Quality Engineer within the industry.
Manager Regulatory Affairs Operations
- Princeton, NJ (8 miles from Dayton, NJ)
- 1 day ago
- Princeton, NJ (8 miles from Dayton, NJ)
- 1 day ago
Please note that this position can be based in San Diego, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. Position Summary The...
Director, Regulatory Affairs Strategy- Oncology
- Princeton, NJ (8 miles from Dayton, NJ)
- 6 days ago
- Princeton, NJ (8 miles from Dayton, NJ)
- 6 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;...
Director, Quality Assurance Operations-CAR-T
- Raritan, NJ (15 miles from Dayton, NJ)
- 7 days ago
- Raritan, NJ (15 miles from Dayton, NJ)
- 7 days ago
Qualifications - External Education: A minimum of a bachelor's degree in Science is required, preferably in Biology, Microbiology, Chemistry, Pharmacy, Biochemistry, Chemical Engineering or related...
Executive Director, Regulatory Affairs
- Princeton Junction, NJ (8 miles from Dayton, NJ)
- 12 days ago
- Princeton Junction, NJ (8 miles from Dayton, NJ)
- 12 days ago
requirements Develops and follows budget allocations All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Doctorate or Masters degree in life sciences (pharmacy, biology...
Senior Director, Regulatory Affairs Global Regulatory Leader
- Princeton Junction, NJ (8 miles from Dayton, NJ)
- 12 days ago
- Princeton Junction, NJ (8 miles from Dayton, NJ)
- 12 days ago
industry, and trade groups as appropriate Follows budget allocations All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor's degree in life sciences (pharmacy, biology...
Director, Regulatory Affairs Business Operations
- Basking Ridge, NJ (21 miles from Dayton, NJ)
- 20 days ago
- Basking Ridge, NJ (21 miles from Dayton, NJ)
- 20 days ago
This role resides in the Global Development area of Regulatory Affairs, Global Patient Safety and Development Quality (RA, GPS and DQ) and the Director of Strategy Planning and Operations role...
Contract Manager, Quality Assurance
- Cranbury, NJ (3 miles from Dayton, NJ)
- 45+ days ago
- Cranbury, NJ (3 miles from Dayton, 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...
Qualifications : Minimum: Bachelor's degree in Pharmacy, Biology, Chemistry or a related field Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial...
Director, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (21 miles from Dayton, NJ)
- 30+ days ago
- Basking Ridge, NJ (21 miles from Dayton, NJ)
- 30+ days ago
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide...
Sr. Director, Quality Assurance PV
- Princeton, NJ (8 miles from Dayton, NJ)
- 45+ days ago
- Princeton, NJ (8 miles from Dayton, NJ)
- 45+ days ago
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our People...
Manager, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (21 miles from Dayton, NJ)
- 45+ days ago
- Basking Ridge, NJ (21 miles from Dayton, NJ)
- 45+ days ago
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...
Associate Director, Regulatory Affairs - Genetic Medicine & Thrombosis
- Basking Ridge, NJ (21 miles from Dayton, NJ)
- 60+ days ago
- Basking Ridge, NJ (21 miles from Dayton, NJ)
- 60+ 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...
Associate Director Quality Assurance Compliance, Hopewell NJ Site
- Hopewell, NJ (15 miles from Dayton, NJ)
- 60+ days ago
- Hopewell, NJ (15 miles from Dayton, NJ)
- 60+ days ago
Core Competencies, Knowledge, and Skill Requirements Scientific degree (ideally chemistry, biology, biotechnology, pharmaceutical sciences or related)....
Senior Director, Regulatory Affairs
- Princeton, NJ (8 miles from Dayton, NJ)
- 90+ days ago
- Princeton, NJ (8 miles from Dayton, NJ)
- 90+ days ago
submissions authoring experience (INDs, IMPDs, NDAs, BLAs, briefing books) Regulatory agency direct interaction experience Strong communications skills Education Requirements: Master's degree in Chemistry, Biochemistry...
Demographic Data for Dayton, NJ
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Dayton, 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
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Flow Cytometry
- Good Clinical Practice
- Real-Time Polymerase Chain Reaction
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Transfection
- Cloning
- Clinical Laboratory Operations
- Cancer Biology
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Laboratory Management
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Collections
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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