Inspection Readiness and Audit Manager

Job description

Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity. Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science. Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture. Inspection Readiness and Audit Manager About the role The purpose of this role is to coordinate external Competent Authorities Pharmacovigilance inspections & License Partners audits of Haleon and support Pharmacovigilance Quality Assurance (PVQA)and GLP, GLP audits activities as appropriate. The role also provides Quality Assurance advisory expertise on Consumer Safety and Clinical Development functions by providing input into the development, management, and implementation of pharmacovigilance (PV) strategies, initiatives, policies, and procedures The role sits within Pharmacovigilance Audits & Inspections department and reports to Head of QPPV & Excellence. Role Responsibilities Coordinate and support regulatory Pharmacovigilance inspections (e.g., FDA, EMA, MHRA, Health Canada, etc.) and License Partner PV audits of Haleon and drive inspection readiness initiatives Support GVP audit activities, including risk rating of audit targets, annual audit planning, and CAPA tracking May support GLP, GCP audit activities, including risk rating of audit targets, annual audit planning, and CAPA tracking Perform desktop audits and support additional audits as needed Authoring of GxP QA written standards and provide quality expertise review and approval in the development and implementation of a CS Quality Management System (QMS) and SOPs in compliance with applicable regulations Generate/support delivery of PVQA and CDQA Management Monitoring and key performance indicator (KPI) metrics to identify trends and drive improvements in Consumer Safety May serve as a Quality partner with Consumer Safety and Clinical Development stakeholders to develop, advise and/or resolve compliance issues, monitor trends and drive quality and processes improvements Provide subject matter expertise (SME) on GVP compliance strategy, quality improvement, and risk assessment, while training and coaching to R&D teams on best practices to foster a strong quality culture and beyond May provide subject matter expertise (SME) on GLP, GCP compliance strategy, quality improvement, and risk assessment, while training and coaching to R&D teams on best practices to foster a strong quality culture and beyond Supports Haleon QPPV as required including but not limited to input to PSMF and collection & collation of data for QPPV oversight (e.g., dashboards, summary reports, etc.) Why you? Basic Qualifications: 6 years of pharmaceutical industry experience in R&D and Quality/Compliance/ Pharmacovigilance/ other areas of vigilance/ Clinical Development/ GLP roles. Audit experience preferred. Demonstrated hands-on experience in inspections conducted by Health Authorities and in inspection readiness. Min. Bachelor of Science Degree; Specialization in Chemistry, Pharmacy, Biology or Life Science, Public Health or Healthcare Provider. Demonstrated ability to influence and negotiate with internal and external stakeholders. Knowledge of global, regional and national GVP GCP GLP regulatory requirements and guidelines. Detailed knowledge of pre and post marketing GVP GCP GLP activities associated with different areas of the business (e.g., clinical trials, manufacturing, regulatory affairs, medical affairs, commercial, toxicology). Self-motivated and quick learner who proactively shares knowledge and welcomes knowledge and feedback from other team members. Ability to deliver key process improvement initiatives. Ability to adapt to changing business and risk environment . Ability to work independently and make decisions with minimal supervision. High degree of organizational awareness and working towards resolution with complex problems. Demonstrated project management skills and management of complex cross-functional activities. Demonstrated good verbal, written and presentation skills. Preferred Qualifications: Master of Science Degree or PhD Biology, Biochemistry, or equivalent Opportunities for growth None of us should ever feel like we are standing still. Instead, we want Haleon to be a place where we feel like we are always progressing. Improving everyday health takes dedication. Energy. Effort. So we look to reward your contribution with a benefits package that includes: Career at one of the leading global consumer companies. Hybrid work. Reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement). Extensive support of work life balance (flexible working solutions including working from home possibilities, health & wellbeing activities) . Private medical care - the cost of the basic package is financed by Haleon. In addition, candidates can extend the selected package to family members and/or partner and purchase the Senior package. P4P Partnership for Prevention. Family benefits (extra parental leave, caregiver’s policy). Life insurance and pension plan. Multisport card or points on the Multicafeteria Benefits account. Personalized learning approach. Supportive community and integration events. Modern office with creative rooms. Free car and bike parking. Remuneration: 17,200 to 23,650 PLN gross/monthly depending on the level of experience and competencies. The salary range for this position is indicative and provided as a guide. The final offer may vary depending on factors including relevant experience, skills, qualifications, and internal equity considerations. Further details regarding the total reward and benefits package will be shared during the recruitment process. Salary ranges may vary by location in line with local market conditions and applicable pay transparency regulations. Location – this role is based in: Warsaw, POLAND Please save a copy of the job description, as this may be helpful to refer to once the advert closes. Job Posting End Date 2026-09-02 Equal Opportunities Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong. During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees. The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions. Adjustment or Accommodations Request If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific adjustments you are requesting. We’ll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence. Note to candidates The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.