Manager of Quality Assurance and Regulatory Affairs Jobs in North Carolina
A Manager of Quality Assurance and Regulatory Affairs in the biotechnology industry is responsible for ensuring that all products and services meet required standards and regulations. They ensure compliance with local, national, and international regulatory requirements, oversee quality control processes, and manage audits and inspections. This role also involves creating and implementing policies and procedures to enhance product quality, efficiency, and safety. They also play a crucial role in the product development process, advising on regulatory requirements and ensuring that compliance is maintained throughout the lifecycle of a product.
Skills required for this role include excellent attention to detail, strong organizational and leadership skills, and in-depth knowledge of regulatory standards and quality control methods. In addition, they should have excellent problem-solving skills, the ability to work under pressure, and strong communication skills. They should also have a strong understanding of biotechnology principles and processes. Certifications such as Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Regulatory Affairs Certification (RAC) are often required. Prior roles that can lead to a Manager of Quality Assurance and Regulatory Affairs include Quality Assurance Specialist, Regulatory Affairs Associate, and Quality Control Supervisor.
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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Manager 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 Manager 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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