About this role
Job Purpose
We are looking for a Manager who provides global leadership and governance of the enterprise Quality Management System (QMS) and Quality Risk Management (QRM) framework across GMP manufacturing, laboratories, supply chain, distribution operations, contract partners and affiliates. This role serves as the corporate process owner for quality systems and ensures compliance, inspection readiness, patient safety, product quality and continuous improvement.
Key Responsibilities
- Govern global Quality Management System and ensure effectiveness of its quality elements e.g. Deviations, CAPA, Change Control, Complaints and Management Review.
- Drive quality metrics, analytics and system trending.
- Establish standards for APR/PQR processes.
- Lead enterprise Data Integrity strategy and oversight.
- Govern Supplier Quality requirements and performance monitoring.
- Lead inspection readiness programs and support major health authority inspections.
- Establish global risk-based auding program.
- Support acquisitions, integrations and global harmonization programs.
Required Education
Bachelor degree in Pharmacy, Chemistry, Engineering, Microbiology or related discipline required. Advanced degree preferred.
Required Skills and Experience
- Minimum 12–15 years of progressive pharmaceutical quality experience including global leadership responsibilities.
- Demonstrated expertise in QMS governance, risk management, compliance, quality culture transformation and cross-functional leadership within multinational pharmaceutical organizations.
- Enterprise mindset, strategic agility, patient-centric decision making, courageous leadership, accountability, talent development, stakeholder influence, change leadership, operational excellence, data-driven decisions, collaboration across cultures, and ability to lead through ambiguity and complexity.
- Success in this role requires strong systems thinking and the ability to understand the interdependencies between quality, manufacturing, supply chain, regulatory, and business objectives.
- The ideal candidate demonstrates exceptional cross-functional collaboration, building alignment across global stakeholders and external partners.
- Strong analytical problem-solving, risk-based decision making, and communication skills are essential to translate complex quality and compliance matters into clear actions and sustainable outcomes.
- Proven project leadership and execution capabilities are critical to drive the effective governance, implementation, and continuous improvement of global Quality Systems and Quality Risk Management processes
Technical Competencies
- Expert knowledge of FDA and EU GMP regulations, WHO GMP, ICH Q7, 9, 10 and EU Guidelines on Good Distribution Practice on Medicinal Products for Human Use.
- Familiar with device and combination product requirements as outlined in FDA 21 CFR Parts 4 and 820 and EU Medical Device Regulations.
- Demonstrated success supporting inspections and remediation programs.
Required Languages
Fluent in English
Salary
Gross Annual Salary starting from: 80.000€
Please note: The salary indicated in this posting complies with local pay transparency regulations for Italian employment contracts. Final offers will be tailored to the successful candidate's experience, professional expertise, and interview journey, while ensuring internal equity. At Recordati, we are committed to a comprehensive, fair, and competitive remuneration system; a full overview of your total rewards package will be shared and discussed with you during the recruiting process.