PMO Sr. Manager, Quality, Regulatory

Job description:

Purpose of the Job

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.

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 (e.g. submissions, inspections 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 (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.

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 (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.

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.