Caring for the world… one person at a time inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products, and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, anchored in the internationally applicable Credo.(Senior) Manager, Pharmacovigilance Audit Programme Lead (m/f/d)Location: Europe (not limited to the countries listed in the job posting)Responsibilities & AccountabilitiesProviding support and input to shape, transform, and execute RDQ QA PV audit strategies for Marketing Partners and Distributors to enhance the effectiveness and sustainability of the audit program while ensuring it meets global regulatory expectations.Independently lead the planning, conduct, and reporting of RDQ QA routine and non-routine audits to assure adherence to corporate policies, internal standards/requirements, and compliance with applicable regulatory requirements.Manage complex or business-critical audits/issues in a supporting or leading role.Manage and maintain audit risk prioritization tools, review risk profiles, provide expert input to risk management strategies, and translate them into PV Marketing Partners and Distributor audit plans and audit scopes, driving continuous improvement and process optimization.Leverage data analytics tools to analyze relevant data sources and evaluate trends and insights 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.Support auditors in scope definition, planning, conduct, and reporting of PV Marketing Partner, Distributor, and cross-sector audits, providing regulatory and process expertise.Provide expert support to auditors and business partners when developing and/or approving CAPAs and drive resolution of complex CAPAs.Proactively seek solutions and contribute to strategic direction to foster robust CAPA processes.Provide support for regulatory inspection activities commensurate with expertise.Support training and development strategies for the team to ensure required skills are available to execute the cross-sector PV audit schedule.Proactively and independently coach others to support talent development and training.Complete assigned training requirements in a timely manner to ensure inspection readiness at all times.This role is either on a Manager or Senior Manager level but does not have direct reports.Deputize for Director, PV Audit Strategy Lead when requested.Take an active role in and lead projects and teams in key project initiatives across the organization.Influence stakeholders and determine priorities, checkpoints, and timelines for all aspects of work and projects.Maintain expert-level knowledge of Pharmacovigilance and PV-related IT, providing critical information, advice, and guidance on complex quality and compliance issues.Independently provide strategic advice to internal or external stakeholders to drive policy and decision-making.Communicate internally to ensure a departmental unified position regarding advice and consultation is provided.Responsible for trending data from the pharmacovigilance audit program including translation of audit trends and outcomes into actionable risk insights.Support the development of digital and data solutions to transform the E2E audit process.QualificationsA minimum of a bachelor's degree is required; an advanced degree is preferred.A minimum of 8 years of experience in the pharmaceutical/biotech industry is required.Pharmacovigilance Quality and Compliance experience is required.Knowledge of Pharmacovigilance and/or QMS audit is required.Audit strategy experience is preferred.Strong collaboration with business partners and strategic thinking is required.Experience with driving culture and change management across a large organization is preferred.Experience with project leadership is preferred.Travel: Up to ~25% travel as per business needs.What we offerOur employees are just as important to us as our customers. At Johnson & Johnson, we like to think long-term and enable successful careers with interesting career paths within our company. We value a healthy balance between work, family, and leisure. Flexible working time models such as part-time, flexible time, and home office can be adapted to your life.Diversity & InclusionFor more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world.
#J-18808-Ljbffr
