Senior Pharmacovigilance Quality Assurance Auditor

Galderma, the world’s largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com

Reporting to the Pharmacovigilance Quality Assurance Manager, Senior PV QA Auditor ensures the deployment and execution of the Quality Management System (QMS) dedicated to Galderma Pharmacovigilance, in line with the global strategy and objectives.

This role oversees Galderma PV projects worldwide including activities carried out by Global Pharmacovigilance, affiliates, and external partners across the three Galderma product categories (drugs, cosmetics, and medical devices).

• Develop and execute the annual audit program dedicated to Galderma Pharmacovigilance systems, processes, and activities:
• Perform internal audits related to PV systems and processes,
• Conduct external audits (affiliates and external partners) of Galderma PV stakeholders,
• Perform PV subcontractor audits and periodically evaluate their quality level with regards to Galderma PV requirements and applicable regulations and coordinate the qualification of external PV partners e.g. through qualification questionnaire,
• Write Audit reports according to applicable procedures and review proposed Corrective and Preventive Actions as applicable,
• Perform peer review of PV QA audit reports.

• Ensure inspection readiness of the PV Quality Management System (Corporate, Affiliates and external partners when required) including preparation, support and follow up of inspections conducted by Competent Authorities
• Carry out independent review of PV documentation (including independent review of the PSMF)
• Contribute to the quality training of PV employees by developing training materials or facilitating training
• Author or provide input to PV Quality documentation, such as procedures, instructions, and forms
• Participate to the quality reviews of the PV quality system including the analysis of Key Performance Indicators to identify trends and signals
• Support Corporate PV in the investigation of deviations related to PV processes and provide quality input into the development of CAPA plans
• Ensure appropriate documentation of any non-compliance impacting the PV System in an electronic Quality Management System (Trackwise)
• Review and/or approve PV Quality documentation (compliance review)
• Foster a PV quality culture in Corporate and Affiliates organizations’ by providing advice from a PV quality perspective

• University Degree in Life Sciences with a background in Pharmacovigilance and Quality Assurance
• 10+ years of experience in Pharmacovigilance and Quality Management function in a global pharmaceutical company
• Experience as a Lead Auditor conducting PV Audits of third parties and affiliates
• Ability to support international projects complying with quality requirements
• Thorough knowledge of cGVP and global regulatory requirements
• Ability to work in a matrix organization with an exposure to cross-functional projects
• Proficient in QMS and Document Management Systems
• Medical Devices experience is a plus
• Team player with a collaborative attitude
• Excellent organization and time management skills
• Continuous improvements mindset – ability to propose improvements and new solutions
• Self-motivated and comfortable in fast-paced company environment
• Strong interpersonal and communication skills
• Willingness to travel
• Fluency in English, written and spoken