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PMO Sr. Manager, Quality, Regulatory & Safety

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Alfasigma

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Location:
Italy , Milano ▼

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Category:
Pharmacy

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Project Manager, Regulatory, Safety & Quality will act as a strategic partner and operational right hand to the Head of Regulatory, Safety & Quality, enabling the effective execution of priorities across the function. The role will coordinate high-impact initiatives, drive cross-functional alignment, support governance and decision-making, and ensure operational excellence across Regulatory Affairs, Pharmacovigilance/Safety, and Quality activities. This position exists to strengthen strategic execution, optimize leadership focus, and ensure consistent, compliant, and timely delivery of Regulatory, Safety & Quality objectives in a highly regulated environment.

Job Responsibility:

  • Translate priorities of the Regulatory, Safety & Quality leadership into actionable plans with clear ownership, timelines, and deliverables
  • Coordinate the definition and monitoring of annual goals, KPIs, and functional business reviews across Regulatory, Safety, and Quality
  • Track progress of key initiatives (e.g. submissions, inspections readiness, safety governance, quality systems) and ensure alignment across internal and external stakeholders
  • Prepare, consolidate, and manage content for leadership team meetings, governance forums, and relevant committees (e.g. Safety Committees, Quality Councils)
  • Act as a thought partner to the Head of Regulatory, Safety & Quality in short- and long-term planning
  • Synthesize complex regulatory, safety, and quality information into clear summaries, dashboards, and recommendations to support decision-making
  • Serve as a central liaison between Regulatory, Safety, Quality, Clinical Development, Operations, Biometrics, and other relevant functions
  • Ensure timely follow-up and accountability on decisions and action items
  • Facilitate effective information flow with external partners, vendors, and consultants where applicable
  • Support and evolve governance frameworks related to Regulatory, Safety, and Quality (e.g. risk management, inspection readiness, compliance oversight)
  • Coordinate functional budgeting, resource planning, and operational processes in partnership with Finance and HR
  • Drive continuous improvement initiatives to enhance efficiency, compliance, and scalability of processes and systems
  • Develop clear and consistent communications aligned with leadership priorities and regulatory expectations
  • Support change management, cross-functional collaboration, and a culture of quality, compliance, and accountability within the function

Requirements:

  • 8+ years of experience in biopharma, life sciences, consulting, or strategy roles
  • Solid exposure to Regulatory Affairs, Pharmacovigilance/Safety, Quality, or closely related development functions
  • Experience working in highly regulated environments is required
  • Advanced degree preferred (PhD, MSc, MD, PharmD, MBA, or equivalent), ideally with a scientific or regulatory background
  • Strong ability to lead through influence in complex, matrixed organizations
  • Excellent organizational, communication, and analytical skills
  • High level of discretion, integrity, and ability to manage sensitive and confidential information
  • Proven experience partnering with senior leaders and coordinating cross-functional initiatives
  • Solid understanding of regulatory, safety, and quality principles within drug development

Additional Information:

Job Posted:
January 04, 2026

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