Our client is a world leading pharmaceutical company, with their HQ in Hessen. For their German RA Division, we're currently looking for a:

- Pharmacovigilance & RQA Lead Auditor

The role of the Pharmacovigilance & Regulatory Quality Assurance (PVRQA) Lead entails spearheading and coordinating initiatives on a global scale within designated regions (Americas, Asia-Pacific (APAC), European Union (EU) under the direction of the PVRQA Regional Head. The main objective is to ensure compliance of our entire Pharmacovigilance (PV) System with relevant regulations, including GVP, ICH GCP guidelines, respective GxP guidelines, international standards, pertinent regulatory requisites, and internal policies.

Working under the guidance of the PVRQA Regional Head, this role involves providing continual operational support for existing PV Quality processes and systems across various departments such as Global Clinical Safety & Pharmacovigilance (GCSP), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA), Affiliates, Commercial Operations, and other interfacing departments within the region.

Key responsibilities include: managing Deviation and CAPA processes, preparing for and managing inspections, overseeing Change Management, driving Continuous Improvement initiatives, ensuring compliance, governance, and reporting standards, managing 3rd Party Qualifications, staying abreast of Regulatory Intelligence, overseeing PV IT Systems, and ensuring Procedural Quality Assurance. Additionally, this role is accountable for developing, maintaining, and executing the Global PVRQA risk-based Audit Program in the respective region, guided by the PVRQA Regional Head.

The position necessitates collaboration and interaction with local, regional, and global stakeholders within GCSP, GRA, GMA, Affiliates Commercial Operations, as well as other relevant local/global interface functions, to deliver support pertaining to PV Quality and processes, including the provision of PV Quality training for the region to facilitate continuous improvement.

Requirements:

• A graduate degree in Scientific Discipline/Life Sciences or related fields, or a bachelor's degree coupled with substantial professional experience
• At least 5 years of experience in the pharmaceutical industry or research/management, with a minimum of 4 years in Pharmacovigilance Quality Assurance or other GxP Quality Assurance roles
• Proficient communication skills encompassing verbal, written, and active listening abilities
• Exceptional critical thinking and analytical capabilities
• Strong problem-solving skills
• Adaptability and resilience in dynamic environments