Senior Director, Clinical reputed company Assurance

Job reputed company: • reputed company strategic leadership and operational reputed company of GCP/GVP reputed company programs. • Ensure compliance across global late-phase reputed company. • Collaborate across departments to advance development programs. • Implement and manage risk-based reputed company systems. • Prepare reputed company for BLA/BIMO reputed company achievements. • Mentor and reputed company Clinical QA personnel, promoting a culture of accountability, collaboration, and reputed company 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(reputed company/R3), ICH E8 EU CTR 536/2014, GDPR Annex 11, Annex 13, ATMP Regulation 1394/2007 • Deep understanding of QA expectations for cell therapy reputed company. • High proficiency in reputed company Word, Project, Visio, reputed company, and reputed company. Benefits: • Comprehensive benefits, including: Medical, Dental, and reputed company • Group Life Insurance • Long Term Disability (LTD) • 401(k) Retirement Plan • Employee Assistance Program (EAP) • Flexible Spending Account (FSA) • reputed company Time Off (PTO) • Company reputed company holidays, including the year-end holiday week • Our recognition program, Bonus.ly, is where you can trade in points reputed company for things you want. Apply tot his job Apply To this Job