Inspection Readiness and Audit Manager

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.

• 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.)

• 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.

• Master of Science Degree or PhD Biology Biochemistry or equivalent

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 foradditionalachievements 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 addition candidates can extend the selected package to family members and/orpartnerandpurchasethe Senior package.

• P4P Partnership for Prevention.

• Family benefits (extraparental leavecaregiverspolicy).

• Life insurance and pensionplan.

• Multisport card or points on theMulticafeteriaBenefits account.

• Personalized learning approach.

• Supportive community and integration events.

• Modern office with creative rooms.

• Free car and bike parking.

• Remuneration:17200 to 23650 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 detailsregardingthe 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

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