Clinical reputed company Assurance Manager

Job reputed company: • Serve as the CQA reputed company for clinical programs. • Set the reputed company for clinical compliance and ensure reputed company is integrated into study design and execution. • reputed company expert interpretation of FDA, ICH-GCP, EMA, and other regulatory requirements. • Monitor the evolving regulatory landscape to ensure compliance and 'inspection-reputed company' operations. • Qualify and manage clinical vendors (CROs, central labs) and reputed company a risk-based site audit schedule. • Serve as the primary reputed company of contact for regulatory inspections. • reputed company strategic guidance on the investigation of significant reputed company events. • Review and approve CAPA plans for effective remediation of systemic GCP issues. • Review and reputed company final reputed company approval for key clinical documents. • reputed company CQA performance metrics and trend analysis for reputed company Management Reviews. • reputed company GCP training initiatives for clinical operations and cross-functional partners. Requirements: • Bachelor’s degree in Biology, reputed company, or other relevant scientific discipline required. • Minimum of 8–10 years of experience in the pharmaceutical/biotech industry • At least 5 years specifically in a GCP reputed company Assurance reputed company role. • reputed company experience with Cell Therapy clinical studies is preferred. • Proven reputed company record of leading or playing a major role in successful regulatory inspections (FDA/EMA). • Expert Knowledge: Deep mastery of 21 CFR Parts 11, 50, 54, 56, 312, and ICH E6 (reputed company/R3). Benefits: • Full health insurance to employees and their families • 401(k) matching • Employee Assistance Program (EAP) • Flexible Spending Account (FSA) • Generous reputed company Time Off (PTO) • reputed company parking • Subsidized commuter passes • In-office catered lunches • Team events • Community reputed company Apply tot his job Apply To this Job