Director of Quality Assurance and Regulatory Affairs Jobs in North Carolina
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.
Senior Director Regulatory Affairs Pharmacy Automation Platform
- Durham, NC
- 1 day ago
- Durham, NC
- 1 day ago
development organizations Ensure Regulatory resources are available to support inspections conducted by global regulators Qualifications: M.S. degree in a technical discipline (e.g., engineering, biology...
Senior Director Regulatory Affairs Pharmacy Automation Platform
- Davis, NC
- 2 days ago
- Davis, NC
- 2 days ago
development organizations Ensure Regulatory resources are available to support inspections conducted by global regulators Qualifications: M.S. degree in a technical discipline (e.g., engineering, biology...
Principal Scientist (Director) - Regulatory Affairs-CMC
- Raleigh, NC
- 5 days ago
- Raleigh, NC
- 5 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...
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...
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
- 9 days ago
- Raleigh, NC
- 9 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...
Lab Manager for the Department of Chemistry Elon University
- Elon, NC
- 14 days ago
- Elon, NC
- 14 days ago
Lab Manager for the Department of Chemistry Location: Elon University Campus Title: Lab Manager for the Department of Chemistry Position Type: Staff Full-Time Days Per Week: Monday - Friday Hours...
Title: Lab Manager for the Department of Chemistry Position Type: Staff Full-Time Days Per Week: Monday - Friday Hours Per Week: 40 VP Area: Office of the Provost and Academic Affairs Department:...
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
- 29 days ago
- Durham, NC
- 29 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...
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
- 30+ days ago
- Durham, NC
- 30+ 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
- 30+ days ago
- Research Triangle Park, NC
- 30+ 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...
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in North Carolina 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
- Employee Development
- 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
- Animal Models
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Biology
- Drug Development
- Biochemistry
- Immunology
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
- Good Manufacturing Practices
- Process Development
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Investigation
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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