Project Manager (Pharma Manufacturing)

Mô tả Công việc
1. Program Leadership & Governance
Establish the EU GMP certification readiness strategy and roadmap.
Provide overall governance for GMP readiness activities across all functional areas.
Ensure alignment between business objectives, regulatory expectations, and operational execution.
Drive accountability across workstream leaders for commitments, milestones, and deliverables.
Lead executive communications and updates to Site leadership team.
Coordinate with other workstream leaders and Site leadership team to assure the defined CAPA completion and the milestone achievement.
2. PMO & Compliance Leadership
Provide strategic leadership and governance for the EU GMP PMO and compliance management framework.
Establish oversight mechanisms to ensure the effectiveness of the integrated master plan, milestone management, action tracking, risk governance, compliance reporting, and escalation pathways.
Review of critical program risks, priorities, and dependencies, ensuring timely escalation for decision-making and removal of barriers through appropriate stakeholder engagement.
Champion cross-functional alignment, governance discipline, and escalated to Site leadership team for resource prioritization to support GMP readiness objectives.
Accountability for program transparency, compliance progress, and executive-level reporting.
3. Performance Monitoring & Continuous Improvement Leadership
Define the framework and strategic direction for GMP readiness performance measurement and KPI governance.
Provide oversight of compliance performance, trend analysis, overdue actions, and effectiveness of corrective and preventive measures.
4. Inspection Readiness & Regulatory Excellence
Establish and maintain a state of continuous inspection readiness.
Organize mock inspections, leadership coaching, SME preparation, front room and back room management, and regulatory response readiness.
Ensure timely and effective observation response and remediation.
5. Risk Management & Escalation
Establish risk-based decision-making processes and maintain the enterprise-level GMP risk register.
Identify critical compliance gaps and drive timely mitigation.
Escalate high-risk issues to Site leadership team and ensure risk ownership and closure accountability across workstreams.
Key Deliverables
Successful EU GMP certification readiness.
Inspection-ready state maintained at all times.
Integrated EU GMP readiness dashboard.
Effective governance and risk management process.
Timely closure of critical compliance gaps.
Sustainable GMP compliance framework.
Positive regulatory inspection outcomes.
Executive visibility of program performance and risks.