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Job FunctionQualityJob Sub FunctionQuality AssuranceJob CategoryProfessionalAll Job Posting Locations: Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Issy-les-Moulineaux, France, Madrid, Spain, Milano, ItalyJob DescriptionPlease note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):United Kingdom, Belgium, Spain, France and Italy - Requisition Number: R-056054Switzerland - Requisition Number: R-059017United States - Requisition Number: R-059013J&J; Innovative Medicine is recruiting for an Associate Director, Pharmacovigilance Audit Programme Lead reporting to the Director, Pharmacovigilance Audit Strategy and to be based in one of the locations where the position has been posted.





The candidate will join the R&D; Quality J&J; Innovative Medicine organization focusing on RDQ QA PV audit strategies for Local Operating Companies (LOCs) and External Supplier Providers (ESPs).

Main Responsibilities

Will Include, But Are Not Limited ToAudit Strategy and AuditingProviding support and input to shape, transform, and execute RDQ QA PV audit strategies for all audit types including Local Operating Companies (LOCs) and External Supplier Providers (ESPs) in order to enhance the effectiveness and sustainability of the audit program, while ensuring the audit program continues to meet integral regulatory expectations.

Manage and mature audit strategy and digital tools in line with evolving regulatory environment and company risk profile.

Manages and maintains audit risk prioritisation tools, reviews risk profiles provides expert input to risk management strategies and translate them into audit plans and audit scopes, driving and shaping continuous improvement and process optimization.

Independently leads the planning, conduct, reporting of RDQ QA routine and non-routine audits to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Manages complex or business critical audits/issues in a supporting or leading role. Leverage data analytics tools to analyze relevant data sources.



Evaluate and analyze the data to identify any relevant trends and insights as an input for the development of the appropriate audit program.

Support continuous improvement in RDQ QA PV audit methodologies.

Advance and enable risk-based auditing as a routine way of working.

Work within RDQ and with business partners to develop and align QA compliance positions.

Supports auditors in the scope definition, planning, conduct and reporting of Pharmacovigilance audits providing regulatory and process expertise within the designated domain.

Provides expert support to auditors and business partners when developing and/or approving CAPAs. Drives resolution of complex CAPAs. Proactively seeks solutions and contributes to strategic direction to foster robust CAPA processes including business partner guidance, appropriateness and timeliness of CAPA activities and management of timelines.

Inspection SupportProvide support for regulatory inspection activities commensurate with expertise.

Training & DevelopmentSupports training and development strategies for team to be able to support PV compliance activities, collaborating within RDQ and with the business as required to ensure required skills are available to execute cross sector PV audit schedule.

Proactively and independently coaches others to support talent development and training to meet current and future business needs.

Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.

People ManagementThis is an individual contributor role.

Deputizes for Director, PV Audit Strategy Lead when requested.

Project ManagementTakes an active role in, and leads, projects and teams in key project initiatives

📌 Associate Director, Pharmacovigilance Audit Programme Lead (Madrid)
🏢 Johnson & Johnson
📍 Madrid