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GMP Project Manager/QA Manager (Pharma)

CÔNG TY CỔ PHẦN GREEN SPEED ·
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Loại hình
Toàn thời gian
Hình thức
Tại văn phòng
Cấp bậc
Trưởng / Phó phòng
Ngành nghề
Sản xuất
Mức lương
Thương lượng
Địa điểm
Hồ Chí Minh, Thành Phố Thủ Đức

Tổng quan

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Bachelor's degree in Pharmacy, Biotechnology, Quality, or equivalence.
  • Proven leadership of complex GMP remediation, transformation, inspection readiness, or regulatory compliance programs.
  • Direct experience supporting EU GMP inspections and regulatory agency interactions.
  • Deep knowledge of: EU GMP, ICH Guidelines, Data Integrity, Validation and Qualification, Quality Systems, Pharmaceutical Manufacturing Operations
  • Strong understanding of risk management and compliance governance
  • Strategic Leadership
  • Fluent in English-4 skills

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