Pharmacovigilance Audit Programme Lead

hace 2 semanas

Madrid, Madrid, España Johnson & Johnson A tiempo completo
Job Summary

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, that are anchored in the internationally applicable Credo.

Responsibilities
  • Provide strategic 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 the audit program continues to meet 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, reviews risk profiles, provides expert input to risk management strategies, and translates them into PV Marketing Partners and Distributor audit plans and audit scopes.
  • 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.
  • Support auditors in the scope definition, planning, conduct, and reporting of PV Marketing Partner, Distributor, and cross-sector audits, providing regulatory and process expertise within the designated domain.
  • Provide expert support to auditors and business partners when developing and/or approving CAPAs, drive resolution of complex CAPAs.
  • Proactively seek solutions and contribute to strategic direction to foster robust CAPA processes, including business partner guidance, appropriateness, and timeliness of CAPA activities, and management of timelines.
  • Support regulatory inspection activities commensurate with expertise.
  • Support training and development strategies for the 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 coach others to support talent development and training to meet current and future business needs.
  • Complete assigned training requirements in a timely manner to ensure inspection readiness at all times.
  • 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 or company, influence stakeholders, and determine priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress.
  • Effectively drive projects to completion.
  • Maintain an 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.
  • Proactively identify the need for and lead information sharing initiatives.
  • Interpret and apply regulations and policies to unique and complex issues to influence decisions and actions.
  • Independently provide strategic advice to internal or external stakeholders to drive policy and decision-making.
  • May serve as a primary contact for internal and external stakeholders and represent RDQ in an expert capacity.
  • Communicate internally to ensure a departmental unified position regarding advice and consultation is provided.
  • Collaborate with relevant business partners, global project teams, CIM, and QRM point(s) of contact to ensure robust audit plans.
  • Responsible to partner closely with RDQ colleagues across sector to ensure 'One' Quality Voice for PV risk assessments, PV audit program; aggregate analysis and management reports (Quality & Business Partners).
  • Responsible for trending of 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, including automated risk-prioritization tools and their maintenance.

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