(Senior) Manager, Pharmacovigilance Audit Programme Lead

"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

(Senior) Manager, Pharmacovigilance Audit Programme Lead (m/f/d)

Location: Europe (not limited to the countries listed in the job posting)

Responsibilities & Accountabilities

Audit Strategy and Auditing:

• Providing support and input to shape, transform, and execute RDQ QA PV audit strategies for Marketing Partners and Distributors in order to enhance the effectiveness and sustainability of the audit program, while ensuring the audit program continues to meet global regulatory expectations.
• 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.
• Manages and maintains audit risk prioritization tools, reviews risk profiles provides expert input to risk management strategies and translate them into PV Marketing Partners and Distributor audit plans and audit scopes, driving and shaping continuous improvement and process optimization.
• 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 PV Marketing Partner, Distributor and cross-sector 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 Support:

• Provide support for regulatory inspection activities commensurate with expertise.

Training & Development:

• Supports 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 Management:

• This role is (depending on experience) either on a 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 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.

Program Expertise:

• Maintains 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 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.
• May serve as a primary contact for internal and external stakeholders and represent RDQ in an expert capacity.
• Communicates 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.
• Interprets and applies regulations and policies to unique and complex issues to influence decisions and actions.
• Responsible 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).
• Responsible for trending of data from the pharmacovigilance audit program including translation of audit trends and outcomes into actionable risk insights.
• Supports the development of digital and data solutions to transform the E2E audit process including automated risk-prioritization tools and their maintenance.