Head Of Quality Systems And Risk Management

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/85h7es

Job PurposeWe 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.
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This role serves as the corporate process owner for quality systems and ensures compliance, inspection readiness, patient safety, product quality and continuous improvement. Key ResponsibilitiesGovern 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 EducationBachelor degree in Pharmacy, Chemistry, Engineering, Microbiology or related discipline required.
Advanced degree preferred.
Required
Skills and ExperienceMinimum ***** 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 processesTechnical CompetenciesExpert 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 LanguagesFluent in EnglishSalaryGross Annual Salary starting from: ******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. xrdztoy
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.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/85h7es