Director of Quality Assurance and Regulatory Affairs Jobs in Rahway, 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.
- Dayton, NJ (19 miles from Rahway, NJ)
- 9 hours ago
- Dayton, NJ (19 miles from Rahway, NJ)
- 9 hours ago
Job Purpose : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that products are...
Director, Quality Assurance and Testing
- New York, NY (17 miles from Rahway, NJ)
- 2 days ago
- New York, NY (17 miles from Rahway, NJ)
- 2 days ago
At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the worlds financial system we touch nearly 20% of the worlds investible...
Director, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (15 miles from Rahway, NJ)
- 4 days ago
- Basking Ridge, NJ (15 miles from Rahway, NJ)
- 4 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...
Regulatory Affairs Director - Oncology
- New York, NY (17 miles from Rahway, NJ)
- 6 days ago
- New York, NY (17 miles from Rahway, NJ)
- 6 days ago
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About...
Manager, Quality Assurance - GxP (GVP)- East Coast Candidates Only
- Warren, NJ (12 miles from Rahway, NJ)
- 8 days ago
- Warren, NJ (12 miles from Rahway, NJ)
- 8 days ago
Knowledge and experience in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and/or Good Clinical Practice (GCP) regulations....
Senior Manager of Quality Assurance
- Livingston, NJ (12 miles from Rahway, NJ)
- 8 days ago
- Livingston, NJ (12 miles from Rahway, NJ)
- 8 days ago
Company: Kelly Services Location: Livingston, NJ Career Level: Mid-Senior Level Industries: Recruitment Agency, Staffing, Job Board Description Kelly Science is seeking a Senior Manager of Quality...
Associate Director of Regulatory Affairs
- New York, NY (17 miles from Rahway, NJ)
- 9 days ago
- New York, NY (17 miles from Rahway, NJ)
- 9 days ago
Your work will change lives. Including your own. The Impact You'll Make Recursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential...
Reporting to the AVP of New Modalities our company's Manufacturing Division Quality, this leader is responsible for supporting the implementation of a unique quality oversight model necessary to...
Manager, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (15 miles from Rahway, NJ)
- 20 days ago
- Basking Ridge, NJ (15 miles from Rahway, NJ)
- 20 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...
- Cranbury, NJ (23 miles from Rahway, NJ)
- 21 days ago
- Cranbury, NJ (23 miles from Rahway, NJ)
- 21 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...
Senior Director, Regulatory Affairs
- Jersey City, NJ (13 miles from Rahway, NJ)
- 21 days ago
- Jersey City, NJ (13 miles from Rahway, NJ)
- 21 days ago
Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP)....
Senior Director, Regulatory Affairs Advertising &
- Parsippany, NJ (18 miles from Rahway, NJ)
- 28 days ago
- Parsippany, NJ (18 miles from Rahway, NJ)
- 28 days ago
at PACIRA PHARMACEUTICALS INC in Parsippany, New Jersey, United States Job Description Overview About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Madison, NJ (12 miles from Rahway, NJ)
- 29 days ago
- Madison, NJ (12 miles from Rahway, NJ)
- 29 days 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...
Senior Director, Regulatory Affairs Advertising & Promotion
- Parsippany, NJ (18 miles from Rahway, NJ)
- 30+ days ago
- Parsippany, NJ (18 miles from Rahway, NJ)
- 30+ days ago
Senior Director, Regulatory Affairs Advertising & Promotion Job ID: 7575 Job Title: Senior Director, Regulatory Affairs Advertising & Promotion Location: Parsippany, NJ Location: (Hybrid)...
Associate Director, Regulatory Affairs - Genetic Medicine & Thrombosis
- Basking Ridge, NJ (15 miles from Rahway, NJ)
- 30+ days ago
- Basking Ridge, NJ (15 miles from Rahway, NJ)
- 30+ 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...
Demographic Data for Rahway, NJ
Moving to Rahway, NJ? Find some basic demographic data about Rahway, 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 Rahway, NJ
Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Rahway, 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
- English
- Quality Systems
- Supplier Management
- Distribution
- Implementation
- Resolution
- Safe Quality Food
- Coaching
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Assay Development
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Drug Discovery
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Troubleshooting
- Quality Control
- Investigation
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Inventory Management
- Regulations
- Teaching
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- 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 »