Director of Quality Assurance and Regulatory Affairs Jobs in Morrisville, 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.
- The University of North Carolina At Chapel Hill
- Chapel Hill, NC (14 miles from Morrisville, NC)
- 2 days ago
- Chapel Hill, NC (14 miles from Morrisville, NC)
- 2 days ago
Posting Information Department: Applied Physical Sciences-318100 Career Area: Administrative/Clerical Support Is this an internal only recruitment?: No Posting Open Date : 06/01/2026 Application...
In Person Part TimeDirector (Senior Director), Regulatory Affairs
- Shattuck Labs, Inc.
- Durham, NC (10 miles from Morrisville, NC)
- 4 days ago
- Durham, NC (10 miles from Morrisville, NC)
- 4 days ago
Provide oversight of Regulatory staff at CRO executing clinical trials. Provide support to clinical study related activities, including interacting with CROs as needed....
In PersonRegulatory Affairs Manager / Senior Regulatory Affairs Manager - Biologics
- United Therapeutics Corporation
- Durham, NC (10 miles from Morrisville, NC)
- 18 days ago
- Durham, NC (10 miles from Morrisville, NC)
- 18 days ago
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 corporation....
HybridDirector, Regulatory Affairs CMC
- PPG US ProPharma Group, LLC
- Raleigh, NC (11 miles from Morrisville, NC)
- 30+ days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 30+ days ago
other international agencies) Deep understanding of CMC regulatory requirements across clinical development, commercialization, and lifecycle management Strong working knowledge of FDA regulations, ICH...
In PersonDirector, Regulatory Affairs - Clinical Strategy
- Azurity Pharmaceuticals
- Raleigh, NC (11 miles from Morrisville, NC)
- 60+ days ago
- Raleigh, NC (11 miles from Morrisville, NC)
- 60+ days ago
trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects,...
HybridAssociate Director, Regulatory Affairs (CMC)
- Kriya Therapeutics
- Morrisville, NC
- 60+ days ago
- Morrisville, NC
- 60+ days ago
Knowledgeable of current US regulatory requirements and ICH guidelines with an understanding of current global and regional trends in regulatory affairs....
In PersonDemographic Data for Morrisville, NC
Moving to Morrisville, NC? Find some basic demographic data about Morrisville, NC below.
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Morrisville, 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
- Continuous Improvement
- Quality Systems
- Quality Management
- Change Control
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Molecular Biology
- ICH Guidelines
- Institutional Review Board
- ICH GCP
- Drug Development
- Clinical Laboratory Operations
- Medical Affairs
- Lab Safety
- Tissue Culture
- Gene Therapy
- Pharmacovigilance
- Biochemistry
- Microbiology
- Biology
- Immunology
- Good Laboratory Practice
- Clinical Trials
- Autoclave
- Lab Experience
- Clinical Research
- Biotechnology
- Laboratory Management
- Equipment Calibration
- Neuroscience
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Strategy Development
- Engineering
- Auditing
- Investigation
- Quality Assurance
- Documentation
- Mentoring
- Interpersonal Skills
- Implementation
- Verbal Communication
- Reporting
- Inventory Management
- Policy Development
- Collaboration
- Education Experience
- Bachelor's Degree
- Regulations
- Research Skills
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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