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.
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
Executive Director, Regulatory Affairs Strategist
- 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,...
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Trenton, NJ
- 6 days ago
- Trenton, NJ
- 6 days ago
This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure...
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Rahway, NJ
- 6 days ago
- Rahway, NJ
- 6 days ago
Job Description This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to...
Minimum 7-10 years in Regulatory Affairs in an FDA Regulated Industry is required Thorough knowledge of ICH Guidelines and FDA cGMPs and Guidelines is required....
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...
Company Name: Datascope Corp.Job Location: 45 Barbour Pond Drive, Wayne, NJ 07470. Employer will allow remote/telecommuting throughout the U.S.Job title: Senior Director Quality & Regulatory...
We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, were all a part of something bigger than...
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...
Associate Director Quality Assurance Compliance, Hopewell NJ Site
- Pennington, NJ
- 17 days ago
- Pennington, NJ
- 17 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...
trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials Supports Head of Department in business development activities including...
Remote WorkAbout Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to...
Senior Validation Manager, Quality Assurance (4849)
- Cranbury, NJ
- 30+ days ago
- Cranbury, NJ
- 30+ 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...
Position Summary The Director of Regulatory Affairs (RA) Labeling will lead the development of a cross-functional labeling strategy for products worldwide, including providing expert input on...
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...
Demographic Data for New Jersey
Moving to New Jersey? Find some basic demographic data about New Jersey 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 New Jersey
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 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
- Electrical Engineering
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Drug Development
- Biology
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
- Process Development
- Diagnostic
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Regulations
- Inventory Management
- Project Management
- Problem Solving
- Research Skills
- 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 »