Director of Quality Assurance and Regulatory Affairs Jobs in Princeton Junction, 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.
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Princeton, NJ (6 miles from Princeton Junction, NJ)
- 16 hours ago
- Princeton, NJ (6 miles from Princeton Junction, NJ)
- 16 hours ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Manager Regulatory Affairs Operations
- Princeton, NJ (6 miles from Princeton Junction, NJ)
- 5 days ago
- Princeton, NJ (6 miles from Princeton Junction, NJ)
- 5 days 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 (6 miles from Princeton Junction, NJ)
- 10 days ago
- Princeton, NJ (6 miles from Princeton Junction, NJ)
- 10 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 (19 miles from Princeton Junction, NJ)
- 11 days ago
- Raritan, NJ (19 miles from Princeton Junction, NJ)
- 11 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...
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Executive Director, Regulatory Affairs
- Princeton Junction, NJ
- 17 days ago
- Princeton Junction, NJ
- 17 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
- 17 days ago
- Princeton Junction, NJ
- 17 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...
Contract Manager, Quality Assurance
- Cranbury, NJ (5 miles from Princeton Junction, NJ)
- 45+ days ago
- Cranbury, NJ (5 miles from Princeton Junction, 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...
- Dayton, NJ (8 miles from Princeton Junction, NJ)
- 30+ days ago
- Dayton, NJ (8 miles from Princeton Junction, NJ)
- 30+ days ago
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...
Associate Director Quality Assurance Compliance, Hopewell NJ Site
- Hopewell, NJ (12 miles from Princeton Junction, NJ)
- 60+ days ago
- Hopewell, NJ (12 miles from Princeton Junction, 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 (6 miles from Princeton Junction, NJ)
- 90+ days ago
- Princeton, NJ (6 miles from Princeton Junction, 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 Princeton Junction, NJ
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Princeton Junction, 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
- Affirmative Action
- Quality Systems
- Implementation
- Resolution
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Good Clinical Practice
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Bioinformatics
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Clinical Trials
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- 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
- Computer Skills
- Leadership
- Communication Skills
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