Pmo Sr. Manager, Quality, Regulatory & Safety

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

Descrizione del lavoro

Una società farmaceutica globale è alla ricerca di un PMO Sr. Manager per gestire le funzioni di Qualità, Regolatoria e Sicurezza. Questa posizione richiede una forte leadership in iniziative strategiche e capacità di coordinazione in ambienti altamente regolati. Si richiedono almeno 8 anni di esperienza, una laurea avanzata e ottime doti analitiche e comunicative. Un'opportunità per contribuire a migliorare la salute e la qualità della vita dei pazienti.

Competenze

• 8+ anni di esperienza in biopharma, scienze della vita o consulenza.
• Forti capacità di leadership in organizzazioni complesse.
• Esperienza in ambienti altamente regolati.

Mansioni

• Tradurre le priorità in piani attuabili con responsabilità chiare.
• Monitorare obiettivi annuali e KPI.
• Sostenere i team di governance e decisione.

Conoscenze

Leadership per influenza

Eccellenti capacità organizzative

Competenze analitiche

Ottime capacità comunicative

Formazione

Laurea avanzata (PhD, MSc, MD, PharmD, MBA)

Descrizione del lavoro

Descrizione dell’offerta di 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.
• Strategic Execution & Functional Planning
  Coordinate the definition and monitoring of annual goals, KPIs, and functional business reviews across Regulatory, Safety, and Quality.
• Strategic Execution & Functional Planning
  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).
• Executive Decision Support
  Act as a thought partner to the Head of Regulatory, Safety & Quality in short‑ and long‑term planning.
• Executive Decision Support
  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.
• Cross‑Functional & External Coordination
  Ensure timely follow‑up and accountability on decisions and action items.
• Cross‑Functional & External Coordination
  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).
• Operations, Compliance & Governance
  Coordinate functional budgeting, resource planning, and operational processes in partnership with Finance and HR.
• Operations, Compliance & Governance
  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.
• Internal Communication & Culture
  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