Experteer Overview In this role you lead quality and compliance for small molecule drug substance manufacturing across external partners in EMEA. You ensure cGMP alignment, risk management, and regulatory readiness while driving continuous improvement and supplier qualification. You collaborate with internal functions and external manufacturers to sustain product quality and supply reliability. You will steer audits, investigations, and quality activities during transfers, scale‑ups, and launches, contributing to JJIM’s mission to deliver high‑quality medicines.Compensaciones / Beneficios - lead external manufacturer qualification and monitoring with a focus on continuous improvement, global alignment, risk management and supply chain reliability - maintain inspection readiness at external manufacturers including on-site representation during regulatory inspections and audits - manage quality activities during manufacturing and quality control including validations, issue management, change management, and supplier/material management - coordinate and execute quality monitoring and auditing activities and quality agreements - assess and improve quality systems and report on quality activities with escalation to senior management as needed - define and monitor quality metrics for external manufacturers and drive improvement opportunities - drive alignment of supplier qualification/monitoring activities with strategic business direction - provide guidance on regulations, directives, J&J standards, and industry guidance related to quality systems - coordinate quality activities supporting new product introductions, process improvements, and significant changes - lead interactions with external manufacturers up to Sr. Management to drive reliability, risk management, and system compliance - build relationships with internal functions (PES, MSAT, EHS, Procurement) and external manufacturersResponsabilidades - Bachelor's degree in Science/Pharmaceutical/Pharmacy/Chemistry/Technical/Synthesis Process technology/Chemical Engineering;
MS/MBA preferred - 6-9 years' experience in Pharmaceutical cGMP environment - experience with small molecule drug substance synthesis, quality management, and external manufacturing - experience in technology transfers, quality event management, and quality system development - ability to manage quality systems and provide cGMP compliance support to external manufacturers - experience handling regulatory inspections and health authority exposure - familiarity with QC/QA practices and analytical techniques (HPLC, GC, IR, wet chemistry) - ability to present issues to all levels of the organization - strong interpersonal skills to influence across functions and geographies - travel up to 40%, willingness to be based in different countries with regional/global travelRequisitos principales -