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Head of quality governance & predictive quality (parma)

Parma
Chiesi Farmaceutici
Pubblicato il Pubblicato 10h fa
Descrizione

Department: Corporate Quality Operations\nBusiness Area: Quality\nJob Type: Direct Employee\nContract Type: Permanent\nLocation:\nParma, IT\nAbout us\nBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here\nWe are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.\nWe believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.\nWe are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.\nChiesi Global Manufacturing Division\nChiesi Group has three production plants:\nParma (Italy), the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries. Here, solid medicines such as tablets and dry powders for inhalers, solutions and suspensions for inhalations and sterile suspension vials for endotracheal administration are produced.\nIn 2024, a new Biotech Centre of Excellence has launched in Parma. The new facility is dedicated to developing and producing monoclonal antibodies, enzymes, and other proteins.\nBlois-La Chaussée Saint Victor plant (France), a center of excellence specializing in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs). The site manages direct distribution to customers in the French market and exports to other markets, effectively meeting both local and international needs.\nSantana de Parnaiba (Brazil), specialized in the production of pressurized solutions and suspensions for inhalation therapy (pMDIs). Additionally, it has an area dedicated to nasal sprays for the European market. Santana produces pressurised solutions and suspensions for inhalation therapy (MDI).\nIn 2025, a new investment in Nerviano (Italy) has been announced with the construction of a new facility which will be primarily dedicated to manufacturing carbon minimal inhalers (reinforcing the company’s commitment to both patients’ health and sustainable healthcare solutions), dry powder inhalers and sterile biological products.\nPosition Overview\nThe Global Head of Quality Governance & Predictive Quality is a senior strategic leader responsible for owning and evolving the global quality governance framework across Chiesi’s GxP operations. This role ensures harmonized quality planning, predictive analytics, and effective escalation and recall processes, while fostering a proactive and data-driven quality culture across the network.\nYou will be responsible for Own and lead the global quality governance structures, including the Quality Plan and tiered Quality Council framework.\nAct as Process Owner for the escalation and recall processes, ensuring timely and effective resolution of quality issues.\nLead the Tier 3 Global Quality Council, driving strategic alignment and decision-making across the network.\nHarmonize KPI data across Chiesi GxP operations, lead KPIs development from Phase III through to commercial affiliates.\nDevelop and implement predictive KPI analytics to proactively identify trends, risks, and opportunities for improvement.\nSupport and optimize electronic platforms for quality governance and data management.\nCollaborate with local quality system process owners to drive best practices, continuous improvement, and global alignment.\nEnsure integration of governance processes with broader QMS and business objectives. You will need to have Bachelor’s degree in Pharmacy, Life Sciences, Engineering, or related field (Master’s or PhD preferred).\nMinimum 15 years of experience in pharmaceutical quality systems, with significant experience in governance and data analytics.\nProven leadership in global quality governance, KPI management, and cross-functional collaboration.\nDeep understanding of GMP/GDP regulations and quality risk management principles. We would prefer for you to have Experience with regulatory inspections and global compliance frameworks.\nExpertise in predictive analytics, digital quality platforms, and data visualization tools.\nStrong stakeholder engagement and communication skills.\nExperience wo

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