Regional Quality Lead (Affiliate Quality Partner)

About the role

The Regional Quality Lead is an affiliate strategic quality partner role. The position covers the affiliate's Quality Management System (QMS) and medical compliance, and supports the oversight of warehousing and distribution partners' quality systems in the subregion, ensuring compliance with local regulations and Roche PQS requirements.

Key responsibilities

• Implement the affiliate QMS framework, prioritising simplification, efficient resource use and timely escalation of issues to the Global function (PDQ)
• Measure the affiliate's medical compliance status, lead the Affiliate Management Reviews and the Medical Compliance Office, and drive continuous improvement of the global QMS
• Lead risk and opportunity management locally, and support audits and inspections
• Support the selection and management of new warehousing and distribution partners, close gaps against long-term GxP-compliance plans, and act as first-level support on product quality topics
• Deliver training to partners, support regional workshops, monitor health authority trends, and help collect and interpret product quality data
• Take on other tasks delegated by the Country Medical Director, such as enabling local digital health solutions, RWE/D and MAP work packages

Required profile

• University degree in life sciences or a similar discipline
• At least 2 years of experience in a biopharmaceutical company or equivalent
• Experience with cross-functional teams and international networks, preferably in a GxP function
• Fluency in French and English

Required skills

• Understanding of ISO quality principles
• Leadership, partnering and networking skills; stakeholder engagement
• Data analytics and qualitative insight
• Familiarity with Agile methodology
• Strong verbal and written communication