PMO Sr. Manager, Quality, Regulatory & Safety Job at Alfasigma (Milano)

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

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PMO Sr. Manager, Quality, Regulatory & Safety

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