Senior Manager GCP Quality
Job Summary
Lead risk-based quality management across assigned clinical trials. Drive protocol-stage Quality Risk Assessment and Control Tracker activities under ICH E6 R3. Manage quality issues, audit responses, corrective actions, preventive actions, and trend analysis. Partner with study leads, monitoring teams, and contract research organizations on site risks. Escalate significant quality events and trends to Executive Quality Leadership. Support inspection readiness, responses, and follow-up actions across relevant functions. Manage onboarding, development goals, coaching, performance discussions, and team administration.
Qualifications
- Bachelor's degree and 8+ years of relevant healthcare or pharmaceutical industry experience
- Quality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice experience
- Advanced risk-based quality management, risk assessment, and compliance knowledge
- Experience managing complex issues, regulatory inspections, and inspection readiness
- Subject matter expert, process owner, training, presentation, and staff management experience
- Process improvement, project management, prioritization, and time management skills
- Advanced Microsoft Outlook, Word, Excel, and PowerPoint skills
- Strong communication, collaboration
What We Offer
Competitive and comprehensive total rewards package including annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.