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.

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.

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.

Senior Director, Clinical Quality Assurance

Key skills