Director of Quality Assurance and Regulatory Affairs Jobs in Franklin Lakes, 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
- Jersey City, NJ (20 miles from Franklin Lakes, NJ)
- 3 days ago
- Jersey City, NJ (20 miles from Franklin Lakes, NJ)
- 3 days ago
Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with Good Clinical Practices (GCP), and General Data Protection Regulation (GDPR)....
Associate Director, Regulatory Affairs
- Elmwood Park, NJ (8 miles from Franklin Lakes, NJ)
- 4 days ago
- Elmwood Park, NJ (8 miles from Franklin Lakes, NJ)
- 4 days ago
Read and understand current FDA guidance(s) and trends, USP general/specific DS/DP monographs, and be familiar with ICH guidelines and post-approval change guidance(s) accordingly....
Senior Manager/Associate Director, Regulatory Affairs - GDP
- Florham Park, NJ (19 miles from Franklin Lakes, NJ)
- 5 days ago
- Florham Park, NJ (19 miles from Franklin Lakes, NJ)
- 5 days ago
Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines. Excellent communication and interpersonal skills....
Director, Regulatory Affairs-- Therapeutic Area Business Manager
- Parsippany, NJ (14 miles from Franklin Lakes, NJ)
- 6 days ago
- Parsippany, NJ (14 miles from Franklin Lakes, NJ)
- 6 days ago
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...
- Parsippany, NJ (14 miles from Franklin Lakes, NJ)
- 6 days ago
- Parsippany, NJ (14 miles from Franklin Lakes, NJ)
- 6 days ago
As a privately- owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate...
Senior Manager, Regulatory Affairs
- Parsippany, NJ (14 miles from Franklin Lakes, NJ)
- 6 days ago
- Parsippany, NJ (14 miles from Franklin Lakes, NJ)
- 6 days ago
Overview About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners...
Qualifications: Bachelors degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field and a m inimum of nine years of experience, or equivalent combination...
Regulatory Affairs Manager New York City
- New York City, NY (23 miles from Franklin Lakes, NJ)
- 18 days ago
- New York City, NY (23 miles from Franklin Lakes, NJ)
- 18 days ago
Qualifications and Skills: Bachelor's degree in life sciences, public health, chemistry, biology, engineering, or other related field....
Manager, Quality Assurance (Advanced Therapies)
- New York, NY (21 miles from Franklin Lakes, NJ)
- 20 days ago
- New York, NY (21 miles from Franklin Lakes, NJ)
- 20 days ago
Regeneron is hiring a Manager, Quality Assurance, to join our team specializing in QA Oversight of our external bulk operations. In this role, you will ensure processes maintain compliance with...
Clinical Lab Manager - Microbiology
- Valhalla, NY (22 miles from Franklin Lakes, NJ)
- 23 days ago
- Valhalla, NY (22 miles from Franklin Lakes, NJ)
- 23 days ago
Clinical Lab Manager - Microbiology#25-00888 Valhalla, NY All On-site Job Description Clinical Lab Manager - Microbiology Valhalla, NY Mon-Fri 8:30am-5pm Job Summary: Under the direction of the...
Associate Director/Director, Regulatory Affairs -GDP Contractor
- Florham Park, NJ (19 miles from Franklin Lakes, NJ)
- 25 days ago
- Florham Park, NJ (19 miles from Franklin Lakes, NJ)
- 25 days ago
Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines. Excellent communication and interpersonal skills....
Director of Regulatory Affairs
- Morristown, NJ (21 miles from Franklin Lakes, NJ)
- 27 days ago
- Morristown, NJ (21 miles from Franklin Lakes, NJ)
- 27 days ago
Director, Regulatory Affairs Location : Morristown, NJ area (2 days per week onsite). Compensation : Base salary up to $220k, Plus Bonus, Plus LTI. Scientific Search has recently partnered with an...
Senior Manager, Regulatory Affairs Advertising & Promotion
- Sleepy Hollow, NY (19 miles from Franklin Lakes, NJ)
- 45+ days ago
- Sleepy Hollow, NY (19 miles from Franklin Lakes, NJ)
- 45+ days ago
The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and...
Demographic Data for Franklin Lakes, NJ
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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in Franklin Lakes, NJ
Required or preferred licenses and certifications for Director of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Franklin Lakes, 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
- Inspections
- ISO 13485
- Quality Management Systems
- Batch Record Review
- GxP
- ICH GCP
- Assay Development
- Institutional Review Board
- Spectrophotometer
- Cancer Research
- Gene Therapy
- Lab Safety
- Molecular Biology
- ICH Guidelines
- Medical Affairs
- Next-Generation Sequencing
- Clinical Laboratory Operations
- Water Testing
- Biology
- Scientific Research
- Microbiology
- Drug Development
- Pharmacovigilance
- Fermentation
- Immunology
- Medical Writing
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Collections
- Strategy Development
- Quality Control
- Auditing
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Inventory Management
- Interpersonal Skills
- Bachelor's Degree
- Policy Development
- Project Management
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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