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.
Master basic biological/biochemistry experiment skills including but limited to cell culture, RT-qPCR, WB, IF....
California, US residents click here (. **The job details are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit...
We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, we're all a part of something bigger than...
- New Port Richey, FL
- 8 days ago
- New Port Richey, FL
- 8 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
- 21 days ago
- Boca Raton, FL
- 21 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...
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
development and process improvement projects Strong background in Next-Generation Sequencing (NGS) and molecular diagnostics....
This position has a $10,000 sign on bonus. (External candidates only.) Labcorp is seeking a Clinical Laboratory Manager to join our team at Ascension St Vincent's Riverside, Jacksonville, Florida....
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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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
- Quality Management
- Change Control
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Institutional Review Board
- ICH GCP
- Animal Models
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Neurobiology
- Lab Safety
- Molecular Biology
- Genotyping
- Polymerase Chain Reaction
- Scientific Research
- Drug Development
- Biochemistry
- Biology
- Immunology
- Medical Writing
- Microbiology
- Scientific Writing
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- General Repair
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Collaboration
- Documentation
- Quality Assurance
- Reporting
- Interpersonal Skills
- Bachelor's Degree
- Education Experience
- Regulations
- Inventory Management
- Policy Development
- Microsoft Office
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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