Compliance Lead, Packaging

At 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. As 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.

Job Function

R&D Operations

Job Sub Function

Clinical Supply Operations

Job Category

Professional

All Job Posting Locations

Beerse, Antwerp, Belgium

Job Description

About Innovative Medicine Our 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. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Compliance Lead, Packaging & Technology. Candidates 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.

Purpose

The Compliance Lead, Packaging & Technology (P&T), serves as the end-to-end compliance subject matter expert for the P&T 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.

You will be responsible for

• Act as the end-to-end compliance lead and subject matter expert for P&T, covering packaging processes and execution, labeling design processes and execution, local warehouse operations, and sample flows.
• Translate applicable ICH-GxP, regulatory, quality-system, data-integrity, policy, and procedural requirements into clear, practical expectations for P&T operations.
• Serve as the primary P&T 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.
• Coordinate inspection readiness across the assigned P&T scope, including preparation, evidence gathering, identification and escalation of key risks, response development, mitigation planning, and follow-up of commitments.
• Liaise with QA, QS, business process owners, R&D Quality, and operational stakeholders to align compliance expectations, priorities, decisions, and actions across the end-to-end P&T organization.
• Monitor 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.
• Guide 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.
• Review and advise on procedures, work instructions, training content, specifications, and compliance controls associated with packaging, labeling, warehousing, and sample handling.
• Support compliant introduction of new products, processes, systems, equipment, suppliers, and operating-model changes by providing timely compliance input and documenting requirements and decisions.
• Participate as the P&T compliance representative in cross-functional operational workstreams and initiatives, providing risk-based guidance and supporting aligned implementation.
• Support onboarding of new team members by providing role-relevant compliance orientation, training guidance, and access to applicable standards and procedures.
• Promote a strong quality and compliance culture, empl