Senior Manager GCP Quality

Responsibilities:
- 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.
- Champion quality, integrity, continuous learning, and trusted partnerships.

Qualifications:
- Bachelor’s degree and eight years’ relevant healthcare or pharmaceutical industry experience.
- Experience in quality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice.
- Advanced risk-based quality management, risk assessment, and compliance knowledge.
- Experience managing complex issues, regulatory inspections, and inspection readiness.
- Subject matter expert with process owner, training, presentation, and staff management experience.
- Process improvement, project management, prioritization, and time management skills.
- Advanced Microsoft Outlook, Word, Excel, and PowerPoint.
- Strong communication and collaboration.

Application instructions:
- Apply now.