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.
years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience Oncology clinical trials or oncology clinical experience Extensive knowledge of ICH...
Clinical Laboratory Manager or Lab Manager in Southern Florida
- Homestead, FL
- 8 days ago
- Homestead, FL
- 8 days ago
NEW Laboratory Manager Opening available in the beautiful Southern Florida! This hospital is a brand new facility and offers a comprehensive range of services including (but not limited to)...
Effective written and verbal communication, collaboration, problem-solving, and negotiation skills General knowledge of Good Manufacturing Practices, Good Clinical Practices, Good Documentation Practices...
Evaluate, develop, recommend, and implement novel laboratory activities and pedagogical strategies particularly for Environmental Science and Biology classes....
Clinical Practice (GCP) and end-to-end regulatory submissions and archival processes Experience compiling and submitting regulatory documents and safety filings Proficiency in Veeva Regulatory Information...
Preferred Certifications ASCP Certification in Molecular Biology (MB) or Clinical Laboratory Director eligibility....
standard lab and plant operating procedures Foster a culture of compliance, professionalism, and continuous development across the lab team Minimum Specifications Education: Bachelor of Science in Biology...
oin Our Team at Tallahassee State College Nursing Lab Manager Opportunity Tallahassee State College is excited to announce a full-time opening for the position of Nursing Lab Manager - P01144 in...
- New Port Richey, FL
- 60+ days ago
- New Port Richey, FL
- 60+ days ago
Company Description ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry-leading practices....
Associate Director, Regulatory Affairs - Plasma Services
- Boca Raton, FL
- 60+ days ago
- Boca Raton, FL
- 60+ days ago
Job Details Job Location: ADMA Biologics FL - Boca Raton, FL Salary Range: Undisclosed Description ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior...
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....
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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in Florida
Required or preferred licenses and certifications for Director of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
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
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Batch Record Review
- GxP
- ICH GCP
- Assay Development
- Institutional Review Board
- Spectrophotometer
- Cancer Research
- Gene Therapy
- Lab Safety
- Molecular Biology
- ICH Guidelines
- Medical Affairs
- Next-Generation Sequencing
- Clinical Laboratory Operations
- Water Testing
- Biology
- Scientific Research
- Microbiology
- Drug Development
- Pharmacovigilance
- Fermentation
- Immunology
- Medical Writing
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Collections
- Strategy Development
- Quality Control
- Auditing
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Inventory Management
- Interpersonal Skills
- Bachelor's Degree
- Policy Development
- Project Management
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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