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.
A client of mine based in North Carolina are looking for a Regulatory CMC Executive Director that has strong, deep and proven expertise in biological and cell therapy products. The appropriate...
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...
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Durham Blackwell Street, Rockville Vaccines, Upper Merion, Waltham Posted Date: Mar 5 2025 Are you looking for a highly...
POSITION RESPONSIBILITIES Ensure all aspects of the Quality system through direct observations and audits, identify and remediate all observations through robust CAPA and determines efficacy of...
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
- 18 days ago
- Durham, NC
- 18 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...
Position at Kymanox I s Kymanox the right fit for you? You want to make a difference and have an impact You enjoy having an influence in your day-to-day work You are motivated by working alongside...
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Durham, NC
- 90+ days ago
- Durham, NC
- 90+ days ago
Site Name: Durham Blackwell Street, USA - Pennsylvania - Upper Providence Posted Date: Nov 5 2024 Job Purpose Ensure the development of appropriate regional regulatory strategy(s) and their...
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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
- English
- Quality Systems
- Supplier Management
- Distribution
- Implementation
- Resolution
- Safe Quality Food
- Coaching
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Assay Development
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Drug Discovery
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Troubleshooting
- Quality Control
- Investigation
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Inventory Management
- Regulations
- Teaching
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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