Director of Quality Assurance and Regulatory Affairs Jobs in Raleigh, NC
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.
Principal Scientist (Director) - Regulatory Affairs-CMC
- Raleigh, NC
- 2 days ago
- Raleigh, NC
- 2 days ago
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
Associate Director, Regulatory Affairs
- Morrisville, NC (11 miles from Raleigh, NC)
- 3 days ago
- Morrisville, NC (11 miles from Raleigh, NC)
- 3 days ago
About Kriya Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary...
- Durham, NC (21 miles from Raleigh, NC)
- 3 days ago
- Durham, NC (21 miles from Raleigh, NC)
- 3 days ago
Minimum Requirements: Knowledge, Skills, Abilities Bachelor degree in pharmaceutical science, biology, chemistry, engineering or related science. 10 years work experience in pharmaceuticals and/or biologics...
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Raleigh, NC
- 6 days ago
- Raleigh, NC
- 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...
Senior Director, Regulatory Affairs
- Morrisville, NC (11 miles from Raleigh, NC)
- 14 days ago
- Morrisville, NC (11 miles from Raleigh, NC)
- 14 days ago
About Kriya Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary...
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...
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...
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Durham, NC (21 miles from Raleigh, NC)
- 26 days ago
- Durham, NC (21 miles from Raleigh, NC)
- 26 days ago
Capable of organising and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority Extensive knowledge of clinical trial and licensing...
Associate Director, Quality Assurance
- Durham, NC (21 miles from Raleigh, NC)
- 27 days ago
- Durham, NC (21 miles from Raleigh, NC)
- 27 days ago
Durham, NC Job Details Full-time Estimated: $113K - $148K a year 1 day ago Qualifications Bachelor of Science English 8 years Bachelor's degree Quality control QA/QC Clinical trials Good Clinical Practice...
Sr. Manager, Quality Assurance- Site Investigations Lead
- Durham, NC (21 miles from Raleigh, NC)
- 28 days ago
- Durham, NC (21 miles from Raleigh, NC)
- 28 days ago
This position is a full-time on-site role (M-F business hours) About This Role The Site Investigations Lead (SIL), Quality Assurance, is responsible for championing the overall investigations...
Sr. Manager, Quality Assurance- Site Investigations Lead
- Research Triangle Park, NC (16 miles from Raleigh, NC)
- 29 days ago
- Research Triangle Park, NC (16 miles from Raleigh, NC)
- 29 days ago
This position is a full-time on-site role (M-F business hours) About This Role The Site Investigations Lead (SIL), Quality Assurance, is responsible for championing the overall investigations...
The incumbent will need to have working knowledge of biotechnology research materials, equipment, reagents, and mammalian cell culture sterile technique....
Demographic Data for Raleigh, NC
Moving to Raleigh, NC? Find some basic demographic data about Raleigh, NC 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 Raleigh, NC
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 Raleigh, NC 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
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Research and Development
- Process Development
- Diagnostic
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Inventory Management
- Regulations
- 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 »