Ph3Experteer Overview /h3pIn this role, you will lead quality oversight of supplier products and CMOs, ensuring GMP and regulatory compliance while coordinating with global teams. 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. /ph3Retribuzione / Benefits /h3ulliOversee GMP supplier network and supplier performance program /liliPlan and execute supplier audits (onsite, postal, remote) and support regulatory inspections /liliPrepare and maintain Technical Quality Agreements (TQAs) clarifying roles and responsibilities /liliManage change control processes for GMP documents, processes, equipment, and facilities /liliReview deviations, CAPAs, investigations, and root causes at suppliers /liliMonitor batch records, validations, and stability programs with suppliers /liliEnsure proper handling of complaints, recalls, and product quality reviews (PQRs) /liliEngage in supplier visits and quality discussions to drive continuous improvement /liliCollaborate with VSOT, ESO, Supply Chain, Procurement, CMC, IMQ, CQA for product lifecycle activities /liliSupport ESQ process deployment and quality‑related projects and reviews /liliPrepare and contribute to issue resolution and supplier development initiatives /liliContribute to SOP meetings with suppliers /liliEnsure readiness for audits and inspections at CMOs /liliSupport product quality investigations and potential corrective actions /liliTravel up to 40% for supplier visits and audits /li /ulh3Responsabilità /h3ulliUniversity degree in Chemistry, Pharmacy or Engineering /liliAt least 4 years of experience in the pharmaceutical industry /liliAuditing experience with knowledge of international GxPs /liliStrong knowledge of international regulatory requirements (PICs, ICH, FDA) and ISO norms /liliUnderstanding of pharmaceutical quality systems and GMP/regulatory guidelines (cGMP, ICH) /liliExperience with QC and stability testing methods /liliFamiliarity with validation activities for manufacturing and packaging processes /liliAbility to manage multiple CMOs and projects in a fast‑paced environment /liliStrong negotiation and communication skills with stakeholders /liliAnalytical mindset, problem‑solving skills and attention to detail /liliWillingness to travel up to 40% /liliAdvanced knowledge of SAP, MasterControl, Power BI /li /ul /p #J-18808-Ljbffr