Experteer OverviewIn this role, you will lead quality oversight of supplier products and CMOs, ensuring GMP and regulatory compliance while coordinating with global teams.
Per il seguente ruolo potrebbero essere richieste diverse soft skill ed esperienze. La preghiamo di consultare attentamente la panoramica riportata di seguito.
You will drive supplier performance, audits, and continuous improvement within a complex supply network that delivers medicines to patients.
You’ll partner with cross‑functional stakeholders to support product lifecycle activities and CMO management.
This is a chance to shape quality standards across the supply chain in a global, collaborative environment.Retribuzione / BenefitsOversee GMP supplier network and supplier performance programPlan and execute supplier audits (onsite, postal, remote) and support regulatory inspectionsPrepare and maintain Technical Quality Agreements (TQAs) clarifying roles and responsibilitiesManage change control processes for GMP documents, processes, equipment, and facilitiesReview deviations, CAPAs, investigations, and root causes at suppliersMonitor batch records, validations, and stability programs with suppliersEnsure proper handling of complaints, recalls, and product quality reviews (PQRs)Engage in supplier visits and quality discussions to drive continuous improvementCollaborate with VSOT, ESO, Supply Chain, Procurement, CMC, IMQ, CQA for product lifecycle activitiesSupport ESQ process deployment and quality‑related projects and reviewsPrepare and contribute to issue resolution and supplier development initiativesContribute to S&OP meetings with suppliersEnsure readiness for audits and inspections at CMOsSupport product quality investigations and potential corrective actionsTravel up to 40% for supplier visits and auditsResponsabilitàUniversity degree in Chemistry, Pharmacy or EngineeringAt least 4 years of experience in the pharmaceutical industryAuditing experience with knowledge of international xjrgpwk GxPsStrong knowledge of international regulatory requirements (PICs, ICH, FDA) and ISO normsUnderstanding of pharmaceutical quality systems and GMP/regulatory guidelines (cGMP, ICH)Experience with QC and stability testing methodsFamiliarity with validation activities for manufacturing and packaging processesAbility to manage multiple CMOs and projects in a fast‑paced environmentStrong negotiation and communication skills with stakeholdersAnalytical mindset, problem‑solving skills and attention to detailWillingness to travel up to 40%Advanced knowledge of SAP, MasterControl, Power BI
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