Senior Director, Clinical Quality Assurance
Job Description:
• Provide strategic leadership and operational oversight of GCP/GVP quality programs.
• Ensure compliance across global late-phase clinical trials.
• Collaborate across departments to advance development programs.
• Implement and manage risk-based quality systems.
• Prepare the team for BLA/BIMO milestone achievements.
• Mentor and develop Clinical QA personnel, promoting a culture of accountability, collaboration, and continuous improvement.
Requirements:
• BS or BA in a scientific discipline required.
• 12+ years of US/EU Clinical QA experience in biologics or pharmaceuticals.
• 5+ years of leadership/supervisory experience.
• Experience in cell therapy and autoimmune programs preferred.
• Commercialization experience a plus.
• Extensive experience with regulatory inspections, vendor qualifications, vendor audits, and internal audits.
• Expert knowledge of global GCP/GVP regulations including: CLIA, CLIP, CAP 21 CFR Parts 11, 50, 54, 56, 312, 320, 812 ICH E6(R2/R3), ICH E8 EU CTR 536/2014, GDPR Annex 11, Annex 13, ATMP Regulation 1394/2007
• Deep understanding of QA expectations for cell therapy clinical trials.
• High proficiency in Microsoft Word, Project, Visio, Excel, and Smartsheet.
Benefits:
• Comprehensive benefits, including: Medical, Dental, and Vision
• Group Life Insurance
• Long Term Disability (LTD)
• 401(k) Retirement Plan
• Employee Assistance Program (EAP)
• Flexible Spending Account (FSA)
• Paid Time Off (PTO)
• Company paid holidays, including the year-end holiday week
• Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
Apply Now
Apply Now
• Provide strategic leadership and operational oversight of GCP/GVP quality programs.
• Ensure compliance across global late-phase clinical trials.
• Collaborate across departments to advance development programs.
• Implement and manage risk-based quality systems.
• Prepare the team for BLA/BIMO milestone achievements.
• Mentor and develop Clinical QA personnel, promoting a culture of accountability, collaboration, and continuous improvement.
Requirements:
• BS or BA in a scientific discipline required.
• 12+ years of US/EU Clinical QA experience in biologics or pharmaceuticals.
• 5+ years of leadership/supervisory experience.
• Experience in cell therapy and autoimmune programs preferred.
• Commercialization experience a plus.
• Extensive experience with regulatory inspections, vendor qualifications, vendor audits, and internal audits.
• Expert knowledge of global GCP/GVP regulations including: CLIA, CLIP, CAP 21 CFR Parts 11, 50, 54, 56, 312, 320, 812 ICH E6(R2/R3), ICH E8 EU CTR 536/2014, GDPR Annex 11, Annex 13, ATMP Regulation 1394/2007
• Deep understanding of QA expectations for cell therapy clinical trials.
• High proficiency in Microsoft Word, Project, Visio, Excel, and Smartsheet.
Benefits:
• Comprehensive benefits, including: Medical, Dental, and Vision
• Group Life Insurance
• Long Term Disability (LTD)
• 401(k) Retirement Plan
• Employee Assistance Program (EAP)
• Flexible Spending Account (FSA)
• Paid Time Off (PTO)
• Company paid holidays, including the year-end holiday week
• Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
Apply Now
Apply Now