Associate Quality Systems Audits and Inspections

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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: Non-Standard Job Sub Function: Workday Associate 01 Job Category: Non-Standard 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   About the Role We are seeking a detail-oriented Associate, CSQ Quality Systems – Audits & Inspections to join our Clinical Supply Quality (CSQ) team. This role is supporting the Sr Associate in planning and coordination of internal and external audits and for the preparation of inspections by health authorities across CSQ, including Beerse (DPDS) , Leiden (ex-Vaccines) , and External Clinical Supply Quality (ECSQ) . The ideal candidate brings solid expertise in GxP quality systems, audit management, and inspection readiness, with a strong focus on planning, documentation, and cross-site coordination.

Audit Planning & Coordination: Support in the maintenance, scheduling and execution of the annual internal and external audit plan across CSQ (Beerse DPDS, Leiden ex-Vaccines, and ECSQ), ensuring identified lead and support auditors, and timely scheduling as per approved audit plan(s). Internal Audits: Support the execution of internal (self-inspection) audits, tracking scope, timelines, findings, and completion of corrective and preventive actions (CAPAs). External Audits: Support the coordination of external audits of suppliers, contract manufacturers, and service providers, aligning stakeholders and consolidating outcomes. Inspection Readiness: Support Sr Associate in the preparation for inspections by health authorities, ensuring sites and teams are inspection-ready through gap assessments, mock inspections, and documentation reviews. Inspection Support: Provide logistical and documentation support during health authority inspections, including management of front-room/back-room activities and request tracking. CAPA & Follow-up: Monitor audit and inspection findings to closure, ensuring responses and CAPAs are robust, timely, and inspection-defensible. Metrics & Reporting: Track and report key audit and inspection metrics (KPIs), providing actionable insights and status updates to CSQ leadership. Documentation & Compliance: Maintain accurate, complete, and audit-ready records in alignment with GxP requirements, ALCOA+ principles, and J&J global standards.

Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field; advanced degree preferred . Minimum 2 – 4 years of experience in quality assurance, quality systems, or audits and inspections within a regulated environment (e.g., pharma, biotech). Strong knowledge of GxP regulations , ICH guidelines, and health authority inspection expectations (e.g., FDA, EMA). Demonstrated experience in