Associate Director, Audit Process Lead, Geel
Associate Director, Audit Process Lead, Geel
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2440 Geel, Belgique
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Publiée: il y a moins d’une semaine
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Description
Overview
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. We are committed to an inclusive work environment that respects the diversity and dignity of our employees.Role
The Associate Director, Audit Process Lead, will be the global, cross-domain Audit Business Process Owner (BPO) for RD&Q, with end-to-end accountability for the RDQ audit process across people, process, and technology. This role will set the strategic direction for the audit process, lead continuous improvement efforts, and ensure the process remains efficient, effective, compliant, and aligned with evolving regulatory expectations and industry leading practices. It will also expand and strengthen RDQ’s partnership with other audit-related functions within J&J, as well as external organizations, to establish a sustainable approach to innovation and audit process modernization. Responsibilities
Audit Strategy&Performance: Set the RDQ audit process strategy and roadmap, focused on continuous improvement to make the process simpler, more consistent, and more efficient, while elevating value to our business partners and supporting better patient outcomes. Establish and monitor meaningful process performance data (e.g., KPIs, KRIs, stakeholder feedback, audit outcomes, inspection learnings, non-conformance trends) to identify and drive improvement opportunities.Explore and identify practical digital enablers that strengthen audit processes, data quality, and user experience, delivering realized value to the organization. Partnerships&Benchmarking: Serve as the RDQ representative in cross-organizational audit forums to share RDQ priorities, influence standards and ways of working, and ensure changes impacting the audit process are aligned with RDQ business needs. Maintain an active external and cross-J&J perspective on audit trends, emerging expectations, and new ways of working to ensure the RDQ audit process continues to evolve with regulatory expectations and business changes. Build strong relationships with other J&J audit-related functions and external organizations to identify leading practices and incorporate relevant learnings into the RDQ audit process. Change Management&Capability Building: Lead change management for audit process updates to ensure RDQ and business partners have a clear understanding of the change and impact, enabling seamless transitions. Ensure audit process guidance, Knowledge Hub content, job aids, communications, and training materials are current, easy to access, and clear enough to support consistent execution across RDQ audit teams.Proactively seek feedback to identify auditor capability needs and set strategy to fill gaps with appropriate tools, training, and upskilling support. Operational Oversight: Lead annual cross-domain audit planning and scheduling, with ongoing monitoring of schedule conformance KPIs. Serve as the central audit process SME for inspections, internal audits, and cross-domain audit process questions that require end-to-end process knowledge and coordinated RDQ input.Support execution of RDQ internal audit program and ensure effective audit and inspection response processes, as needed. Oversee audit process-related impact assessments, non-conformance management, and critical issue resolution, ensuring appropriate SME input, timely follow-through, and sustainable process fixes.Facilitate external audit response management, as needed, including effective resolution of issues. Serve as backup for auditors during periods of high workload or unforeseen circumstances to ensure business continuity. Qualifications
Bachelor’s degree in a scientific, medical, technical, or related discipline. A minimum of 8 years of experience in pharmaceutical, healthcare, or adjacent industries, ideally within GxP environments (e.g., GCP, GLP, GMP). Demonstrated experience conducting audits (internal or external), including planning, execution, reporting, and follow-up.Ability to think strategically to elevate multi-disciplinary practices, driving process improvement, leveraging efficiency&lean principles, and executing change management. Ability to innovate by identifying gaps, exploring digital or alternative solutions, building the case for change, and leading implementation to deliver value. Strong capability in performance management, using data-driven insights, metrics, KPIs to drive measurable enhancements.Strong project management capabilities, including an ability to balance priorities across multi-workstream initiatives, resolve roadblocks, and escalate appropriately. Excellent interpersonal, oral, and written communication skills to effectively influence cross-functionally and engage externally to our organization and J&J, to ensure leading practices are being adopted. Proficiency in English (written and verbal). Availability for limited travel (10% potentially, driven by business need). Benefits&Compensation
The anticipated base pay range for this position is:€96,000.00 - €165,025.00. Benefits: In addition to base pay, we offer various benefits including an annual bonus with target pay dependent on location and performance, vacation days, parental leave, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and health insurance options where applicable. Specifics vary by location.For more information, visit Johnson&Johnson Careers.
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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. We are committed to an inclusive work environment that respects the diversity and dignity of our employees.Role
The Associate Director, Audit Process Lead, will be the global, cross-domain Audit Business Process Owner (BPO) for RD&Q, with end-to-end accountability for the RDQ audit process across people, process, and technology. This role will set the strategic direction for the audit process, lead continuous improvement efforts, and ensure the process remains efficient, effective, compliant, and aligned with evolving regulatory expectations and industry leading practices. It will also expand and strengthen RDQ’s partnership with other audit-related functions within J&J, as well as external organizations, to establish a sustainable approach to innovation and audit process modernization. Responsibilities
Audit Strategy&Performance: Set the RDQ audit process strategy and roadmap, focused on continuous improvement to make the process simpler, more consistent, and more efficient, while elevating value to our business partners and supporting better patient outcomes. Establish and monitor meaningful process performance data (e.g., KPIs, KRIs, stakeholder feedback, audit outcomes, inspection learnings, non-conformance trends) to identify and drive improvement opportunities.Explore and identify practical digital enablers that strengthen audit processes, data quality, and user experience, delivering realized value to the organization. Partnerships&Benchmarking: Serve as the RDQ representative in cross-organizational audit forums to share RDQ priorities, influence standards and ways of working, and ensure changes impacting the audit process are aligned with RDQ business needs. Maintain an active external and cross-J&J perspective on audit trends, emerging expectations, and new ways of working to ensure the RDQ audit process continues to evolve with regulatory expectations and business changes. Build strong relationships with other J&J audit-related functions and external organizations to identify leading practices and incorporate relevant learnings into the RDQ audit process. Change Management&Capability Building: Lead change management for audit process updates to ensure RDQ and business partners have a clear understanding of the change and impact, enabling seamless transitions. Ensure audit process guidance, Knowledge Hub content, job aids, communications, and training materials are current, easy to access, and clear enough to support consistent execution across RDQ audit teams.Proactively seek feedback to identify auditor capability needs and set strategy to fill gaps with appropriate tools, training, and upskilling support. Operational Oversight: Lead annual cross-domain audit planning and scheduling, with ongoing monitoring of schedule conformance KPIs. Serve as the central audit process SME for inspections, internal audits, and cross-domain audit process questions that require end-to-end process knowledge and coordinated RDQ input.Support execution of RDQ internal audit program and ensure effective audit and inspection response processes, as needed. Oversee audit process-related impact assessments, non-conformance management, and critical issue resolution, ensuring appropriate SME input, timely follow-through, and sustainable process fixes.Facilitate external audit response management, as needed, including effective resolution of issues. Serve as backup for auditors during periods of high workload or unforeseen circumstances to ensure business continuity. Qualifications
Bachelor’s degree in a scientific, medical, technical, or related discipline. A minimum of 8 years of experience in pharmaceutical, healthcare, or adjacent industries, ideally within GxP environments (e.g., GCP, GLP, GMP). Demonstrated experience conducting audits (internal or external), including planning, execution, reporting, and follow-up.Ability to think strategically to elevate multi-disciplinary practices, driving process improvement, leveraging efficiency&lean principles, and executing change management. Ability to innovate by identifying gaps, exploring digital or alternative solutions, building the case for change, and leading implementation to deliver value. Strong capability in performance management, using data-driven insights, metrics, KPIs to drive measurable enhancements.Strong project management capabilities, including an ability to balance priorities across multi-workstream initiatives, resolve roadblocks, and escalate appropriately. Excellent interpersonal, oral, and written communication skills to effectively influence cross-functionally and engage externally to our organization and J&J, to ensure leading practices are being adopted. Proficiency in English (written and verbal). Availability for limited travel (10% potentially, driven by business need). Benefits&Compensation
The anticipated base pay range for this position is:€96,000.00 - €165,025.00. Benefits: In addition to base pay, we offer various benefits including an annual bonus with target pay dependent on location and performance, vacation days, parental leave, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and health insurance options where applicable. Specifics vary by location.For more information, visit Johnson&Johnson Careers.
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Informations clefs
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Nom de l’entreprise7555-Janssen Pharmaceutica NV Legal Entity
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Titre de posteAssociate Director, Audit Process Lead
Conseils de Sécurité
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Informations supplémentaires sur l’annonce
Associate Director, Audit Process Lead est visible sur Locanto dans la catégorie Geel Informatique, télécommunications.
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