Associate Director Business Engagement

h3Job Function: /h3pLegal Compliance /p h3Job Sub Function: /h3pEnterprise Compliance /p h3Job Category: /h3pPeople Leader /p h3All Job Posting Locations: /h3pBeerse, Antwerp, Belgium /p h3Job Description: /h3pJohnson Johnson is currently recruiting for Associate Director Business Engagement This position can be performed at any US or EMEA JJ location. /p pThe position builds and maintains mutually beneficial relationships with the JJ business partners
- focusing on the segment of the business they are aligned to. Through proactive engagement across the supply chain and ERC areas, the position will actively collect stakeholder feedback and business insights to enhance ERC (JJIA) knowledge of existing and new products / technology / GxP services either currently in use or planned within the JJ. This strategic role ensures the ERC (JJIA) audit programs remain current. /p pThe position uses insights obtained along with relevant regulatory requirements to develop audit strategies based on a 'fit for purpose' mindset. This position also drives continuous improvement of the ERC (JJIA) audit program, including setting the ERC (JJIA) auditor strategies. /p pThe position will support standardization all ERC (JJIA) audit support activities, driving improved and economized audit preparation, including risk-based scheduling, resourcing, pre-audit planning based on site type, products, technology and potential linkages to other sites, regions and site types. Supporting to the objective of providing a holistic view of potential compliance risks across the JJ supply chain. /p pThe position additionally leads the digital enablement of the ERC (JJIA) audit program through design, development, and maintenance of data analytics and visualization solutions that deliver near-real-time audit program performance insights. The position manages enterprise audit system records, oversees the development and maintenance of annual audit schedules, and drives automation and process standardization across the end-to-end audit lifecycle. The role also serves as a subject matter expert and system champion for next-generation quality platforms, supporting system testing, user enablement, and cross-functional adoption. /p h3Key

Responsibilities:
/h3 p25% /p pEstablish effective business relationships with key stakeholders within the JJ supply chain that will enable insights that are used to define ERC (JJIA) audit strategies. /p pProactively engages business partners to collect insights on products, technology, GxP services, acquisitions, and divestitures, and translates these insights into actionable audit program strategies. Serves as primary liaison between the ERC audit team and Innovative Medicines quality and compliance stakeholders. /p p20% /p pLeads the development and ongoing maintenance of the annual Innovative Medicines and External Manufacturer (EM) audit schedule, including creation and management of audit records. Partners with Innovative Medicines EQ to drive audit execution, remove barriers, and maintain alignment with enterprise audit commitments and governance standards. /p p20% /p pLeads the design, development, and continuous improvement of Pre-Audit Intelligence Packages, integrating data from enterprise quality systems and AI-enabled tools to generate actionable pre-audit intelligence. Executes ERC site risk profiles for Internal and External sites, conducts quarterly audit data trend analysis, and provides audit program performance metrics reporting in support of JJRC Compliance reviews and quarterly stakeholder reporting. /p p10% /p pAssists in formulating implementing ERC (JJIA) audit procedure improvements to be followed by the ERC (JJIA) auditors. /p p10% /p pMaintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings. Assesses proposed regulations and communicates new requirements to the organization. Provides regulatory compliance subject matter expertise (SME) in support of acquisition and divestiture due diligence activities, new product initiatives, and supplier/EM audit refusal and risk assessment processes. Completes Innovative Medicine Pharmacovigilance System Master File (PSMF) contributions for ERC audits as required, and supports health authority and internal audits of the audit program as a SME /p p10% /p pDrives digital enablement and data analytics innovation across the ERC (JJIA) audit program by developing and maintaining real-time reporting dashboards, supporting integration of audit management system data, and evaluating and implementing artificial intelligence solutions to enhance compliance analysis, pre-audit intelligence, and audit program performance visibility. Identifies and leads process automation opportunities to reduce manual effort and increase efficiency across end-to-end audit lifecycle activities. /p p5% /p pOther work-related duties as assigned. /p h3Qualifications: /h3 h3Education: /h3 pA minimu