Manager of Quality Assurance and Regulatory Affairs Jobs in Greenville, SC
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.
Overview Develops, implements, and maintains the activities of quality assurance systems. Oversees the Batch Records review and releases and implementation of standards, methods, and procedures...
Demographic Data for Greenville, SC
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Salary for Manager of Quality Assurance and Regulatory Affairs Jobs in Greenville, SC
Required or preferred licenses and certifications for Manager of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Greenville, SC 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
- Verbal Communication
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Assay Development
- Biomarkers
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Genotyping
- Lab Safety
- Next-Generation Sequencing
- Molecular Biology
- Cloning
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Western Blot
- Biology
- Stem Cells
- Microbiology
- Good Laboratory Practice
- Biotechnology
- Clinical Trials
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Microsoft Office
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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