PMO Sr. Manager, Quality, Regulatory & Safety

Alfasigma; Milano; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A global pharmaceutical company is seeking a PMO Sr. Manager, Quality, Regulatory & Safety. The candidate will facilitate cross-functional initiatives and ensure operational excellence across Regulatory Affairs, Pharmacovigilance/Safety, and Quality activities. An ideal candidate should have 8+ years of experience in biopharma and advanced degrees preferred. This full-time role based in Milan focuses on strategic execution and governance support while promoting a culture of quality and accountability.

Competenze

• 8+ years of experience in biopharma, life sciences, consulting, or strategy roles.
• Solid exposure to Regulatory Affairs, Pharmacovigilance/Safety, Quality.
• Experience in highly regulated environments is required.

Mansioni

• Coordinate and monitor annual goals, KPIs, and functional reviews.
• Prepare content for leadership team meetings and governance forums.
• Support governance frameworks related to Regulatory, Safety, and Quality.

Conoscenze

Leadership

Analytical skills

Communication

Formazione

PhD, MSc, MD, PharmD, MBA or equivalent

Descrizione del lavoro

PMO Sr. Manager, Quality, Regulatory & Safety

Join to apply for the PMO Sr. Manager, Quality, Regulatory & Safety role at Alfasigma

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.

Principal Accountabilities

Strategic Execution & Functional Planning

• 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 (submissions, inspection readiness, safety governance, quality systems) and ensure alignment across internal and external stakeholders.

Executive Decision Support

• Prepare, consolidate, and manage content for leadership team meetings, governance forums, and relevant committees (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.

Cross‑Functional & External Coordination

• 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.

Operations, Compliance & Governance

• Support and evolve governance frameworks related to Regulatory, Safety, and Quality (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.

Internal Communication & Culture

• 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.

Qualifications

• 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.

Company

Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. It has offices in many countries, including Italy, the US, Spain, Germany, Mexico, and China; production sites in Italy (Pomezia, RM; Alanno, PE; Sermoneta, LT; Trezzano Rosa, MI), Spain (Tortosa, Baix Ebre), and the United States (Shreveport, Louisiana); and R&D labs in Italy (Pomezia and Bergamo). Alfasigma employs approximately 4,000 people dedicated to research, development, production, and distribution of medicinal products, contributing to its mission to provide better health and a better quality of life for patients, caregivers, and healthcare providers. It focuses on three main therapeutic areas: Gastroenterology, Vascular, and Rheumatology. Its portfolio spans from primary care to specialty care, rare disease medications, and consumer health products, including medical foods and nutraceuticals.

Seniority level

Mid-Senior level

Employment type

Full‑time

Job function

Public Relations

Industries

Pharmaceutical Manufacturing