Director Pharmacovigilance Audit Expert

Job Description – Director Pharmacovigilance Audit Expert (2506231619W) Description At 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 https://www.jnj.com/ . Main responsibilities will include, but are not limited to: Audits Shape and transform R&D Quality pharmacovigilance tactical and operational level audit plans to improve the efficiency and sustainability of the audit program; while ensuring it continues to meet global regulatory expectations. Act as the primary QA contact with global business partners to develop and align QA compliance positions in audit execution. Accountable for audit execution strategies supporting auditors to build PV audit plans and scopes. Accountable for audit resourcing ensuring all audits are adequately resourced as per risks identified, complexity, auditors’ experience and development. Leads \’for cause\’, complex and business critical pharmacovigilance audits and assures adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Guides auditors in the scope definition, planning, conduct and reporting of PV domain audits, providing regulatory and process expertise. Influences consistency of CAPAs for similar issues across regions and with relevant partners to drive efficiencies in business operations and compliance levels. Serves as backup for auditors during periods of high workload or unforeseen circumstances to ensure business continuity. Ensures regional quality through establishment and maintenance of oversight mechanisms (e.g. audit report peer review) as appropriate. Drives innovation on audit methodologies, data gathering and data analytics in line with evolving Regulatory environment. Leads and maintains the training programme for Pharmacovigilance Auditors. Develops training and development strategies to support PV domain compliance activities, to ensure required skills are available to complete the PV domain audit schedule. Ensures that each team member is knowledgeable about compliance and maintains awareness of new PV legislation and guidance. Proactively and independently coaches team to support talent development and training, delivers effective leadership to shape a collaborative and efficient auditor organization. Develops and is involved in the review and approval of training curriculum. Completes assigned training requirements in a timely manner to always ensure inspection readiness. Actively monitors auditor skills and recommends actions to ensure the organization can meet objectives and maintain global alignment. Deputizes for QA Domain Head and as back up for Regional Team Leads when requested. Implements talent strategies in a standard and fair way to ensure audit skills remain current to support business objectives. Cultivates an environment which encourages the company’s Credo commitment to equal employment opportunity and the value of a diverse workforce. Ensures appropriate QA representation on site initiatives and policy reviews that impact the team and support an effective working environment. Stays updated on the latest technology trends and innovations ensuring adequate audit coverage. Inspection Support Will support pharmacovigilance inspection activities commensurate with expertise as appropriate. Assists with PV QA activities related to HA Inspections, including readiness and coordination with other functions as needed. Project and Process Management Leads projects and teams in key project initiatives across the organization or company. Determines priorities, checkpoints, and timelines. Effectively drives projects to completion. Maintains pharmacovigilance audit procedural document framework, ensuring that all audit processes, methodologies and guidelines are accurately detailed, regularly updated and aligned with Regulatory Requirements. Operates as a Pharmacovigilance technical expert. Maintains expert level of Pharmacovigilance and Quality Management Systems knowledge with the ability to provide critical information, advice and mentorship on complex issues. Promotes implementation of innovative QA audit methodologies focusing on reaching deeper quality and compliance insights. Supports auditors to leverage data analytics tools to analyze relevant data sources, identify any relevant trends and insights as an input for the development of the appropriate audit program. 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 partners to drive policy and decision making. Serves as a primary contact for global internal and external partners and represents R&D Quality in an expert capacity. Collaborate with relevant business partners and global project teams to ensure robust audit plans. Qualifications A minimum of 12 years of experience in Pharmacovigilance Quality Assurance, or related fields within the pharmaceutical Industry, at a Health Authority, or CRO (Contract Research Organisation). Leadership experience including managing PV audit programmes and teams. Proven experience in conducting and overseeing global pharmacovigilance audits. Demonstrated experience with regulatory inspections preferred. Bachelor’s degree in Life Sciences, Pharmacy, or a related field. A Master’s degree or advanced qualifications are preferred. In-depth understanding of global pharmacovigilance regulations and guidelines. Strong leadership skills, including the ability to mentor and develop staff. Excellent analytical and problem-solving skills to address complex compliance issues. Exceptional communication skills (written and verbal). Ability to manage multiple priorities and deadlines in a fast-paced environment. Location: Belgium, Beerse or UK are preferred. Other locations preferably within EMEA can be considered. Please note: We are pleased to announce that from mid-2026, our offices in Wokingham and High Wycombe will move into a modern, state-of-the-art Johnson & Johnson office in central Maidenhead, conveniently situated next to the train station. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location Europe/Middle East/Africa-United Kingdom-England-High Wycombe #J-18808-Ljbffr