Compliance Lead, Packaging

pAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at jnj.com . /p pAs guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. /p pbJob Function: /b /p pRD Operations /p pbJob Sub Function: /b /p pClinical Supply Operations /p pbJob Category: /b /p pProfessional /p pbAll Job Posting Locations: /b /p pBeerse, Antwerp, Belgium /p pbJob Description: /b /p pbAbout Innovative Medicine /b /p pOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. /p pJoin us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. /p pLearn more at /p pbWe are searching for the best talent for Compliance Lead, Packaging Technology. /b /p pCandidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position. Candidates authorized to work pursuant to a short-term status (e.g., F-1) who require future immigration sponsorship are not eligible. /p pbPurpose: /bThe Compliance Lead, Packaging Technology (PT), serves as the end-to-end compliance subject matter expert for the PT organization. Reporting to the Logistics and Compliance Lead, the role provides compliance leadership and practical guidance across packaging processes and execution, labeling design processes and execution, local warehouse activities, and sample flows. This manager-level individual contributor partners with operational and functional stakeholders to maintain a state of control, ensure adherence to applicable GxP and quality-system requirements, and support reliable clinical supply. The role has no direct people-management responsibility. /p pbYou will be responsible for: /b /p pAct as the end-to-end compliance lead and subject matter expert for PT, covering packaging processes and execution, labeling design processes and execution, local warehouse operations, and sample flows. /p pTranslate applicable ICH-GxP, regulatory, quality-system, data-integrity, policy, and procedural requirements into clear, practical expectations for PT operations. /p pServe as the primary PT compliance contact for internal and external audits and Health Authority inspections, coordinating readiness activities and supporting demonstration of end-to-end process integrity and compliance. /p pCoordinate inspection readiness across the assigned PT scope, including preparation, evidence gathering, identification and escalation of key risks, response development, mitigation planning, and follow-up of commitments. /p pLiaise with QA, QS, business process owners, RD Quality, and operational stakeholders to align compliance expectations, priorities, decisions, and actions across the end-to-end PT organization. /p pMonitor and communicate compliance metrics, trends, and emerging risks; maintain fit-for-purpose compliance governance, routines, risk registers, and action tracking, and provide evidence-based recommendations to the Logistics and Compliance Lead. /p pGuide issue management for deviations, investigations, CAPAs, change controls, periodic reviews, and other quality-system processes, ensuring appropriate preventive and corrective actions are defined, tracked, and effectively implemented to uphold operational integrity. /p pReview and advise on procedures, work instructions, training content, specifications, and compliance controls associated with packaging, labeling, warehousing, and sample handling. /p pSupport compliant introduction of new products, processes, systems, equipment, suppliers, and operating-model changes by providing timely compliance input and documenting requirements and decisions. /p pParticipate as the PT compliance representative in cross-functional operational workstreams and initiatives, providing risk-based guidance and supporting aligned implementation. /p pSupport onboarding of new team members by providing role-relevant compliance orientation, training guidance, and access to applicable standards and procedures. /p pPromote a strong quality and compliance culture, employee engagement, inclusion, and adherence to Credo Behaviors by coaching stakeholde