07 ago - Parma
Chiesi Farmaceutici
ppSelect how often (in days) to receive an alert: /p /brpDepartment: Corporate Quality Operations /p /brpBusiness Area: Quality /p /brpJob Type: Direct Employee /p /brpContract Type: Permanent /p /brpLocation: Parma, IT /p /brpbAbout us /b /p /brpChiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here. /p /brpAt Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Agevolazioni Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /p /brpDiversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. /p /brpbGlobal Technical Operations Supply /b /p /brpGlobal Technical Operations Supply (Global TechOpS) is Chiesi’s global manufacturing and supply area, responsible for ensuring consistent, outstanding quality, service and value across our end‑to‑end supply chain. Global TechOpS oversees the entire lifecycle of the drug: from process optimization and industrialization, to manufacturing, engineering, quality oversight, and supply chain management. Throughout this journey, Operational Excellence drives continuous improvement. This end‑to‑end model is powered by our four manufacturing sites - Parma (IT), Blois (FR), Santana de Parnaíba (BR), and Nerviano (IT) - together with our Virtual Plant network of external partners. /p /brh3bThis is what you will do /b /h3 /brpWe are looking for an experienced quality leader to drive the global oversight and lifecycle management of suppliers supporting Chiesi's pharmaceutical network. The position reports directly to the Global Quality Operations VP and leads a small team of Quality Subject matter experts. /p /brpThe role is responsible for defining and implementing the global supplier quality strategy across Active Pharmaceutical Ingredients (APIs), excipients, primary and secondary packaging materials, Device Constituent Parts (DCPs) used in inhalation products, and other critical GxP suppliers supporting both sterile and non‑sterile products. /p /brpActing as the global quality owner for supplier management, the position ensures a harmonized qualification, performance monitoring, risk management and governance framework across the manufacturing sites of Chiesi Farmaceutici SPA. /p /brpThe role works in close collaboration with Global Procurement, Manufacturing Sites, Regulatory Affairs, Technical Development, External Quality and Supplier Audit functions to ensure consistent supplier quality oversight throughout the supply chain. /p /brpAs this is a newly established global function, the role will require strong commitment, senior leadership engagement and the ability to promote, embed and lead a new approach across the organization.
/p /brh3bYou will be responsible for /b /h3 /brul /brliDefining the global supplier qualification and requalification strategy for APIs, excipients, packaging materials, Device Constituent Parts and critical GxP suppliers. /li /brliEnsuring consistent supplier qualification standards and processes across all manufacturing sites. /li /brliGoverning supplier approval, conditional approval, probation and disqualification decisions. /li /brliMaintaining oversight of the Approved Supplier List and supplier lifecycle status. /li /brliEnsuring supplier qualification activities support business continuity and long‑term supply strategies. /li /br /ul /brpbSupplier Quality Governance /b /p /brul /brliEstablishing and maintaining the global supplier quality governance framework. /li /brliDefining global standards, policies and procedures for supplier quality management. /li /brliProviding supplier quality metrics to senior leadership and Leading escalation forums /li /brliDriving harmonization of supplier quality processes across sites. /li /brliDefining and monitoring supplier quality KPIs and performance indicators. /li /brliOverseeing supplier scorecards, performance trending and quality reviews. /li /brliIdentifying recurring quality issues and driving effective improvement plans with suppliers. /li /brliSupporting procurement and business stakeholders in supplier performance evaluations. /li /brliEscalating critical supplier quality concerns and ensuring appropriate mitigation actions. /li /br /ul /brpbSupplier Quality Risk Management /b /p /brul /brliImplementing a risk‑based framework for supplier oversight to define a risk mitigation strategy and supporting business continuity plans. /li /brliLeading supplier risk and criticality assessments. /li /br /ul /brpbSupplier Quality Events Management /b /p /brul /brliProviding quality oversight for supplier‑related deviations, investigations, complaints, SCARs and CAPAs. /li /brliEnsuring timely escalation and resolution of critical supplier quality events. /li /brliMonitoring effectiveness of corrective and preventive actions implemented by suppliers. /li /brliGoverning supplier‑initiated changes impacting materials, components, processes or services. /li /brliEnsuring appropriate quality and regulatory impact evaluations. /li /brliSupporting implementation and effectiveness monitoring of supplier changes. /li /brliEnsuring adequate communication and alignment across impacted functions and sites. /li /br /ul /brpbQuality Agreements Management /b /p /brul /brliDefining the global strategy and standards for Supplier Quality Technical Agreements. /li /brliOverseeing approval, maintenance and periodic review of quality agreements. /li /brliManaging escalations related to supplier obligations and compliance commitments. /li /br /ul /brh3bYou will need to have /b /h3 /brul /brliUniversity degree in Pharmacy, Chemistry, Biotechnology, Engineering or other relevant scientific disciplines. /li /brliSignificant experience (bnot less than 10 years /b) in pharmaceutical quality management and supplier quality oversight. /li /brliStrong knowledge of GMP requirements applicable to APIs,
excipients, packaging materials and combination products. /li /brliProven experience managing global supplier qualification and governance programs. /li /brliStrong knowledge of supplier quality risk management, change management and quality systems. /li /brliFluent English, both written and spoken. /li /brliDemonstrated leadership experience in complex global and cross‑functional environments. /li /br /ul /brh3bWe would prefer for you to have /b /h3 /brul /brliExperience with inhalation products and Device Constituent Parts. /li /brliExperience managing global supplier networks supporting multiple manufacturing sites. /li /brliKnowledge of FDA, EMA and international regulatory expectations for supplier oversight. /li /brliExperience in business continuity and supply chain risk management. /li /br /ul /brh3bSoft Skills /b /h3 /brul /brliStrategic leadership /li /brliInfluencing and stakeholder management /br /liliDecision‑making capability /li /brliRisk‑based thinking /li /brliCollaboration and teamwork /li /brliCustomer and patient focus /li /br /ul /brh3bLocation /b /h3 /brpThe primary work location is Parma (HQ Italy). The role offers flexibility, allowing candidates to be based in one of Chiesi affiliates across Europe, with regular travel to Parma required. /p /brh3bCompensation Range /b /h3 /brpThe minimum salary for this role is € 74.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience,qualificationsand internal equity considerations. /p /brpThis role is eligible toparticipatein an annual bonus scheme, subject to company and individual performance. /p /brpIn addition, we offer a comprehensive benefits package including company car, pension, private medical insurance, wellbeing programme, flexible benefits programme. /p /brpThe package outlined above is based on the rolebeing located inItaly. Where the role is offered in a different country, the applicable salary,bonusand benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at theappropriate stageof the recruitment process. /p /brpbWhat we offer /b /p /brpNo matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. /p /brpWe provide top‑class benefits, including comprehensive healthcare programs, work‑life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. /p /brpChiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination. /p /p #J-18808-Ljbffr
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