Manager of Quality Assurance and Regulatory Affairs Jobs in Raleigh, NC
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.
Sr. Director, Quality Assurance
- Cary, NC (8 miles from Raleigh, NC)
- 4 days ago
- Cary, NC (8 miles from Raleigh, NC)
- 4 days ago
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...
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...
Associate Director Of Quality Assurance Clinical Operations
- Durham, NC (21 miles from Raleigh, NC)
- 21 days ago
- Durham, NC (21 miles from Raleigh, NC)
- 21 days ago
Keywords: Gene Therapy, Genetic Disorders, Biotechnology, Molecular Biology, Biopharmaceuticals, Quality Assurance, GXP, Veeva Vault, FDA Regulations, Clinical Trials, Quality Management Systems, AAV...
Director, Quality Assurance - Analytical
- Durham, NC (21 miles from Raleigh, NC)
- 45+ days ago
- Durham, NC (21 miles from Raleigh, NC)
- 45+ days ago
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...
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...
Associate Director, Regulatory Affairs
- Morrisville, NC (11 miles from Raleigh, NC)
- 90+ days ago
- Morrisville, NC (11 miles from Raleigh, NC)
- 90+ days ago
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...
Demographic Data for Raleigh, NC
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Raleigh, NC 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
- 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
- Transfection
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Biochemistry
- Microbiology
- Biology
- Stem Cells
- Immunology
- 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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