Director of Quality Assurance and Regulatory Affairs Jobs in Bridgewater, 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.
Director Regulatory Affairs Labeling
- Princeton, NJ (15 miles from Bridgewater, NJ)
- 4 days ago
- Princeton, NJ (15 miles from Bridgewater, NJ)
- 4 days ago
Job Order Number: DE9874268 Job Title: Director Regulatory Affairs Labeling Company: ACADIA PHARMACEUTICALS INC Location: Princeton, NJ Salary: Education: Bachelor's Degree Experience: 7 years...
Senior Manager/Associate Director, Regulatory Affairs - GDP
- Florham Park, NJ (16 miles from Bridgewater, NJ)
- 5 days ago
- Florham Park, NJ (16 miles from Bridgewater, 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 (21 miles from Bridgewater, NJ)
- 6 days ago
- Parsippany, NJ (21 miles from Bridgewater, 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...
Director Regulatory Affairs, Tactical Implementation
- Bridgewater, NJ
- 6 days ago
- Bridgewater, NJ
- 6 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,...
- Parsippany, NJ (21 miles from Bridgewater, NJ)
- 6 days ago
- Parsippany, NJ (21 miles from Bridgewater, 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 (21 miles from Bridgewater, NJ)
- 6 days ago
- Parsippany, NJ (21 miles from Bridgewater, 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...
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 Director, Regulatory Affairs
- Hampton, NJ (19 miles from Bridgewater, NJ)
- 11 days ago
- Hampton, NJ (19 miles from Bridgewater, NJ)
- 11 days ago
Overview Celldex is a clinical-stage biotechnology company dedicated to developing novel antibody-based treatments that improve the lives of patients with allergic, inflammatory and autoimmune...
- Hampton, NJ (19 miles from Bridgewater, NJ)
- 11 days ago
- Hampton, NJ (19 miles from Bridgewater, NJ)
- 11 days ago
guidelines Interpret scientific data and study results to support the development of clear, concise regulatory documents Collaborate cross-functionally with Clinical Development, CMC, Quality, Program...
Associate Director/Director, Regulatory Affairs -GDP Contractor
- Florham Park, NJ (16 miles from Bridgewater, NJ)
- 25 days ago
- Florham Park, NJ (16 miles from Bridgewater, 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 (14 miles from Bridgewater, NJ)
- 27 days ago
- Morristown, NJ (14 miles from Bridgewater, 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...
- Princeton, NJ (15 miles from Bridgewater, NJ)
- 45+ days ago
- Princeton, NJ (15 miles from Bridgewater, NJ)
- 45+ days ago
About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the...
Executive Director, Regulatory Affairs Strategist
- Bridgewater, NJ
- 45+ days ago
- Bridgewater, NJ
- 45+ 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,...
Demographic Data for Bridgewater, NJ
Moving to Bridgewater, NJ? Find some basic demographic data about Bridgewater, NJ below.
Director of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job titles
Salary for Director of Quality Assurance and Regulatory Affairs Jobs in Bridgewater, 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 Bridgewater, 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
Other Career Titles
Here are some other career titles that require similar skills
Director of Quality Assurance and Regulatory Affairs Related Career Advice Articles
4 Biotech Opportunities & Career Paths With High Growth Potential
Biotechnology is an emerging segment of the employment market with opportunities spanning healthcare, biopharmaceuticals, agriculture, industry, and academia. If you have a thirst for innovation, this career path might be right for you!
Read article »