ppAt 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. /p pAs 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. /p h3Job Function /h3 pbQuality /b /p h3Job Sub Function /h3 pbQuality Assurance /b /p h3Job Category /h3 pbProfessional /b /p h3All Job Posting Locations: /h3 pBeerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Issy-les-Moulineaux, France, Madrid, Spain, Milano, Italy /p h3Job Description /h3 pPlease 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): /p ul liUnited Kingdom, Belgium, Spain, France and Italy - Requisition Number: R- /li liSwitzerland - Requisition Number: R- /li liUnited States - Requisition Number: R- /li /ul pJJ Innovative Medicine is recruiting for an bAssociate Director, Pharmacovigilance Audit Programme Lead /b 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 RD Quality JJ Innovative Medicine organization focusing on RDQ QA PV audit strategies for Local Operating Companies (LOCs) and External Supplier Providers (ESPs). /p h3Main Responsibilities Will Include, But Are Not Limited To /h3 h3Audit Strategy and Auditing /h3 ul liProviding 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 global regulatory expectations. /li liManage and mature audit strategy and digital tools in line with evolving regulatory environment and company risk profile. /li liManages 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.



/li liIndependently 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. /li liSupport continuous improvement in RDQ QA PV audit methodologies. /li liAdvance and enable risk-based auditing as a routine way of working. /li liWork within RDQ and with business partners to develop and align QA compliance positions. /li liSupports auditors in the scope definition, planning, conduct and reporting of Pharmacovigilance audits providing regulatory and process expertise within the designated domain. /li liProvides 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. /li /ul h3Inspection Support /h3 ul liProvide support for regulatory inspection activities commensurate with expertise. /li /ul h3Training Development /h3 ul liSupports 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. /li liProactively and independently coaches others to support talent development and training to meet current and future business needs. /li liCompletes assigned training requirements in a timely manner to ensure inspection readiness at all times. /li /ul h3People Management /h3 ul liThis is an individual contributor role. /li liDeputizes for Director, PV Audit Strategy Lead when requested. /li /ul h3Project Management /h3 ul liTakes an active role in, and leads, projects and teams in key project initiatives across the organization or company. Influences stakeholders and determines priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress. Effectively drives projects to completion.



/li /ul h3Program Expertise /h3 ul liMaintains expert level of Pharmacovigilance and PV related IT knowledge with the ability to provide critical information, advice and guidance on complex quality and compliance issues. /li liProactively identifies the need for and leads information sharing initiatives. Interprets and applies regulations and policies to unique and complex issues to influence decisions and actions. Independently provides strategic advice to internal or external stakeholders to drive policy and decision making. /li liMay serve as a primary contact for internal and external stakeholders and represent RDQ in an expert capacity. /li liCommunicates internally to ensure a departmental unified position regarding advice and consultation is provided. /li liCollaborate with relevant business partners, integral project teams and RDQ colleagues to ensure robust audit plans. /li liInterprets and applies regulations and policies to unique and complex issues to influence decisions and actions /li liResponsible to partner closely with RDQ colleagues across sector to ensure “One” Quality Voice for PV risk assessments, PV audit programme; aggregate analysis and management reports (Quality Business Partners). /li liResponsible for trending of data from the pharmacovigilance audit program including translation of audit trends and outcomes into actionable risk insights. /li liSupports the development of digital and data solutions to transform the E2E audit process including automated risk-prioritization tools and their maintenance. /li /ul h3Qualifications /h3 ul liA minimum of a bachelor’s degree is required. An advanced degree is preferred. /li liA minimum of 8 years of experience in the pharmaceutical/biotech industry is required. /li liFluent knowledge of English language. /li liPharmacovigilance Quality and Compliance experience is required. /li liExperience in Pharmacovigilance audit required. /li liExperience working with digital tools and systems is required. /li liAudit strategy experience is preferred. /li liStrong collaboration with business partners and strategic thinking required. /li liExperience with driving culture and change management across a large organization is preferred. /liliExperience with project leadership preferred. /li /ul h3Travel Requirements /h3 ul liUp to ~25% travel as per business needs. /li /ul h3Applicable just for the United Kingdom job posting /h3 pPlease note that our office will be relocating to central Maidenhead from October 2026. Applicants should ensure that this location is suitable for them. /p h3Required Skills /h3 pPharmaceutical Compliance, Pharmacovigilance /p h3Preferred Skills /h3 pCompliance Management, Good Manufacturing Practices (GMP), ISO 9001, Quality Auditing, Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP) /p /p #J-18808-Ljbffr

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