Director of Quality Assurance and Regulatory Affairs Jobs in New Jersey
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 Principal Scientist (Associate Director) Regulatory Affairs
- Rahway, NJ
- 1 hour ago
- Rahway, NJ
- 1 hour ago
Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry Required Experience and Skills: At least five (5) years of relevant experience, including biological/pharmaceutical...
Associate Director, Regulatory Affairs Advertising & Promotion Compliance
- Princeton, NJ
- 2 days ago
- Princeton, NJ
- 2 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;...
An established company in the flavor and fragrance industry is seeking an experienced Laboratory Manager to lead its Essential Oils Division. This role focuses on the development and production of...
Job Details Manufacturing / Warehouse Lab Manager Cherry Hill, NJ Job Description Job ID#: 114471 Category: Manufacturing / Warehouse Job Type: Permanent Branch: Cherry Hill Salary: $ 85000.00 - $...
The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients...
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
- 24 days ago
- Bridgewater, NJ
- 24 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,...
MS or PhD in chemistry or biology and/or Regulatory Affairs is strongly preferred....
California, US residents click here (. **The job details are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit...
Associate Director Quality Assurance Compliance, Hopewell NJ Site
- Pennington, NJ
- 30+ days ago
- Pennington, NJ
- 30+ days ago
**_Core Competencies, Knowledge, and Skill Requirements_** + Scientific degree (ideally chemistry, biology, biotechnology, pharmaceutical sciences or related). + Minimum of 8 years of experience in...
Senior Validation Manager, Quality Assurance (4849)
- Cranbury, NJ
- 45+ days ago
- Cranbury, NJ
- 45+ days ago
Job Title - Senior Validation Manager, Quality Assurance Work Location - Cranbury NJ Responsibilites: Manages the QA Validation process at WuXi Biologics BioDEV USA Accountable for QA Review of...
Thorough knowledge of US and international regulations as they apply to pharmaceutical drug development....
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 Scientist/Associate Director, Regulatory Affairs CMC
- Basking Ridge, NJ
- 60+ days ago
- Basking Ridge, NJ
- 60+ days ago
Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...
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,...
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in New Jersey 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
- Continuous Improvement
- Affirmative Action
- Quality Systems
- Implementation
- Quality Management
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Animal Models
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Neurobiology
- Molecular Biology
- Clinical Laboratory Operations
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Laboratory Information Management System
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Education Experience
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Policy Development
- Bachelor's Degree
- Inventory Management
- Regulations
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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