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Or839 | Senior) Manager, Pharmacovigilance Audit Programme Lead
hace 2 meses
.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 & AccountabilitiesAudit Strategy and Auditing: Providing 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, ensuring it meets global regulatory expectations. Independently leads 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. Manages complex or business-critical audits/issues in a supporting or leading role. Manages and maintains audit risk prioritization tools, reviews risk profiles, provides expert input to risk management strategies, and translates them into PV Marketing Partners and Distributor audit plans and audit scopes, driving continuous improvement and process optimization.Inspection Support: Provide support for regulatory inspection activities commensurate with expertise.Training & Development: Supports training and development strategies for the team to support PV compliance activities, collaborating within RDQ and with the business to ensure required skills are available to execute the cross-sector PV audit schedule. Proactively coaches others to support talent development and training.People Management: This role is either at Manager or Senior Manager level but does not have direct reports. Deputizes for Director, PV Audit Strategy Lead when requested.Project Management: Takes an active role in, and leads projects and teams in key project initiatives across the organization. Influences stakeholders and determines priorities, checkpoints, and timelines for all aspects of work and projects.Program Expertise: Maintains expert level of Pharmacovigilance and PV related IT knowledge, providing critical information, advice, and guidance on complex quality and compliance issues.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 required.Audit strategy experience is preferred
