Director of Quality Assurance and Regulatory Affairs Jobs in Cary, 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.
Manager, Quality Assurance Audits and Supplier Qualifications
- Morrisville, NC (7 miles from Cary, NC)
- 5 days ago
- Morrisville, NC (7 miles from Cary, NC)
- 5 days ago
What You Bring to the Team Education & Experience Bachelor’s degree in science/technical field (e.g., biochemistry, bioengineering, clinical research, etc.), or equivalent combined education and experience...
Senior Manager, Regulatory Affairs
- Raleigh, NC (8 miles from Cary, NC)
- 6 days ago
- Raleigh, NC (8 miles from Cary, NC)
- 6 days ago
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe...
Verdesian Life Sciences is in search of an individual to fill the role of Regulatory Affairs Manager in the corporate office in Cary, North Carolina. Individual should already reside in the...
- Raleigh, NC (8 miles from Cary, NC)
- 19 days ago
- Raleigh, NC (8 miles from Cary, NC)
- 19 days ago
Experience in lab safety procedures and maintaining a safe work environment....
Molecular Lab Manager - Tuesday-Saturday (3:00pm-11:30pm)
- Durham, NC (17 miles from Cary, NC)
- 28 days ago
- Durham, NC (17 miles from Cary, NC)
- 28 days ago
Passionate about precision medicine and advancing the healthcare industry? With the advent of genomic sequencing, we can finally decode and process our genetic makeup. We now have more data than...
Demographic Data for Cary, NC
Moving to Cary, NC? Find some basic demographic data about Cary, NC below.
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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in Cary, 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 Cary, 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
- Verbal Communication
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Assay Development
- Biomarkers
- Flow Cytometry
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Next-Generation Sequencing
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Biology
- Stem Cells
- Microbiology
- Biotechnology
- Clinical Trials
- Good Laboratory Practice
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Policy Development
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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