Director of Quality Assurance and Regulatory Affairs Jobs in Florida
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.
WHO WE ARE & WHAT WE DO Tallahassee Memorial Healthcare (TMH) is a private, nonprofit community-based healthcare system that provides care to a 22-county region in North Florida and South Georgia....
Clinical Lab Manager Employer Proclinical Staffing Location Florida, USA, Lake Mary Salary Highly Competitive Salary Start date 4 Mar 2025 Closing date 18 Mar 2025 categories Apply now Click to...
Actalent is Hiring a Lab Manager Job Description The Laboratory Manager is responsible for maintaining a positive operating margin, achieving the annual budget, and ensuring cost control. They...
About the role Standard Chartered Bank is seeking a meticulous and strategic professional for the role of Associate Director, Exam Management. This critical position involves overseeing regulatory...
Vertex Applied Innovation Hub is Florida Tech's industry-facing innovation center, located five miles south of the main campus in Palm Bay. Housed in a 100,000 sq. ft. facility (formerly known as...
Sr. Research Scientist - part time Lab Manager
- Saint Petersburg, FL
- 30+ days ago
- Saint Petersburg, FL
- 30+ days ago
Sr. Research Scientist - part time Lab Manager University of South Florida, United States about 22 hours ago Location: Saint Petersburg, FLORIDA Department: Department of Surgery / 0-6120-037...
Labcorp is seeking a Clinical Laboratory Manager to join our team at Ascension St Vincent's Riverside, Jacksonville, Florida. This position will be responsible for overseeing the operations and...
Labcorp is seeking a Clinical Laboratory Manager to join our team at Ascension Riverside Hospital in Jacksonville, FL. This position will be responsible for overseeing the operations and...
Join Our Team at Tallahassee State College Nursing Lab Manager Opportunity Are you passionate about higher education and eager to make a real impact? Do you thrive in a collaborative environment,...
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Director of Quality Assurance and Regulatory Affairss in Florida 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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