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.
Laboratory Operations Manager or Lab Manager in North Carolina
- Winston Salem, NC
- 8 hours ago
- Winston Salem, NC
- 8 hours ago
New Laboratory Operations Manager at an award winning hospital in North Carolina! This teaching hospital offers a comprehensive list of services including (but not limited to) cancer care,...
Laboratory Manager or Lab Manager at Top Health System
- Salisbury, NC
- 8 hours ago
- Salisbury, NC
- 8 hours ago
New Laboratory Operations Manager at an award winning hospital in North Carolina! This teaching hospital offers a comprehensive list of services including (but not limited to) cancer care,...
Job Summary The Cell Processing Lab Manager is an integral leader within our growing cross-market Transplantation and Cellular Therapy Program. Oversees all aspects of the Novant Health Weisiger...
Creo Director, Quality and Regulatory Compliance in Durham , North Carolina JOB DESCRIPTION OVERVIEW The Director, Quality and Regulatory Compliance, will lead a team responsible for delivering...
Sr. Director, Quality Assurance at Heron Therapeutics Cary, NC Heron Therapeutics develops cutting-edge medicine to meet unmet patient needs and solve big problems by applying our innovative...
Gpac has an exciting opportunity for a Quality Director position in KY. The company produces sliced meat for one of the largest big-box stores in America. This plant operates 24/7 across three...
Associate Director Of Quality Assurance Clinical Operations
- Durham, NC
- 26 days ago
- Durham, NC
- 26 days ago
Keywords: Gene Therapy, Genetic Disorders, Biotechnology, Molecular Biology, Biopharmaceuticals, Quality Assurance, GXP, Veeva Vault, FDA Regulations, Clinical Trials, Quality Management Systems, AAV...
Labcorp is seeking a Clinical Laboratory Manager to join our team in Burlington, NC. This position will be responsible for overseeing the operations and administration of the clinical laboratory...
Position Summary: Leads and directs all QA activities supporting analytical laboratory operations in a contract manufacturing organization. Responsible for review of certificates of analysis for...
Lecturer/Lab Manager - Applied Engineering Technology
- Greensboro, NC
- 90+ days ago
- Greensboro, NC
- 90+ days ago
The Lecturer/Lab Manger will contribute to teaching and perform instruction-related duties and responsibilities in accordance with the mission, policies, and procedures of the University. Engages...
Regulatory Science Lead (Associate Director of Regulatory Affairs)
- Raleigh, NC
- 90+ days ago
- Raleigh, NC
- 90+ days ago
Make your mark for patients We are looking for a Regulatory Science Lead (Associate Director of Regulatory Affairs) who is a proactive, collaborative, and strategically minded individual to join...
Demographic Data for North Carolina
Moving to North Carolina? Find some basic demographic data about North Carolina below.
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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in North Carolina
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 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
- Quality Systems
- Supplier Management
- Implementation
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Institutional Review Board
- Cell Biology
- Assay Development
- Flow Cytometry
- Real-Time Polymerase Chain Reaction
- Transfection
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Drug Development
- Clinical Laboratory Operations
- Cell Culture
- Genotyping
- DNA Isolation
- Biochemistry
- Microbiology
- Biology
- Stem Cells
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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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!
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