Experteer Overview
In 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.
Retribuzione / Benefits
* Oversee GMP supplier network and supplier performance program
* Plan and execute supplier audits (onsite, postal, remote) and support regulatory inspections
* Prepare and maintain Technical Quality Agreements (TQAs) clarifying roles and responsibilities
* Manage change control processes for GMP documents, processes, equipment, and facilities
* Review deviations, CAPAs, investigations, and root causes at suppliers
* Monitor batch records, validations, and stability programs with suppliers
* Ensure proper handling of complaints, recalls, and product quality reviews (PQRs)
* Engage in supplier visits and quality discussions to drive continuous improvement
* Collaborate with VSOT, ESO, Supply Chain, Procurement, CMC, IMQ, CQA for product lifecycle activities
* Support ESQ process deployment and quality‑related projects and reviews
* Prepare and contribute to issue resolution and supplier development initiatives
* Contribute to S&OP meetings with suppliers
* Ensure readiness for audits and inspections at CMOs
* Support product quality investigations and potential corrective actions
* Travel up to 40% for supplier visits and audits
Responsabilità
* University degree in Chemistry, Pharmacy or Engineering
* At least 4 years of experience in the pharmaceutical industry
* Auditing experience with knowledge of international GxPs
* Strong knowledge of international regulatory requirements (PICs, ICH, FDA) and ISO norms
* Understanding of pharmaceutical quality systems and GMP/regulatory guidelines (cGMP, ICH)
* Experience with QC and stability testing methods
* Familiarity with validation activities for manufacturing and packaging processes
* Ability to manage multiple CMOs and projects in a fast‑paced environment
* Strong negotiation and communication skills with stakeholders
* Analytical mindset, problem‑solving skills and attention to detail
* Willingness to travel up to 40%
* Advanced knowledge of SAP, MasterControl, Power BI
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