Director of Quality Assurance and Regulatory Affairs Jobs in Mississippi
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.
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Mississippi 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
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- TrackWise
- Institutional Review Board
- Assay Development
- Biomarkers
- CRISPR
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Genotyping
- Next-Generation Sequencing
- Cell Culture
- Mammalian Cell Culture
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Confocal Microscopy
- Polymerase Chain Reaction
- Drug Development
- Western Blot
- Biology
- Pharmacovigilance
- Stem Cells
- Microbiology
- Enzyme-Linked ImmunoSorbent Assay
- Clinical Trials
- Good Laboratory Practice
- Biotechnology
- Clinical Research
- Laboratory Management
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Strategy Development
- Engineering
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Education Experience
- Inventory Management
- Reporting
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Teamwork
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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