CHC Distributors Quality Lead LATAM

Job description

Main responsibilities:

Support the Business Teams in charge of the management of Distributors in LatAm countries operating via Distributor Business Model set-up, by ensuring an appropriate quality oversight/level of control on those Distributors.

·  Operational management of all quality matters reported by/impacting the local Distributors marketplaces, in full compliance with applicable regulatory requirements and company standards:
·  Product Complaints
·  Quality events (deviations; quality alerts, quality risks)
·  Recalls
·  Temperature excursions
·  Oversight of destruction by receiving certificate
·  Coordination across SANOFI CHC in relation to activities executed by the Distributors in scope:
·  Repackaging/Redressing operations (regular follow-up on all operations performed including coordination of certification by the original manufacturing site Qualified Person per need, regular review/update or corresponding Quality agreements)
·  Routine Quality Control importation testing, request internal standards and dispatch to corresponding country, ensure transfer of methods to distributors is done (e.g. Chile, Uruguay, upcoming Paraguay)
·  Support random packaging inspections by local Health Authorities per need 
·  Contribution to the assessment of the Product Quality Reviews (PQRs) by the Marketing Authorization Holder (MAH) in the “Distributors Business Model countries” when applicable
·  Management of Changes impacting the assigned Distributors. For change requests coming from distributors: follow-up of the implementation.
·  Quality management of assigned Distributors
·  Qualification/Quality assessment of Distributors
·  Regular operational meetings with Distributors, Annual Quality Review
·  Training of Distributors personnel to SANOFI CHC processes & ways of working
·  Annual review/update of Quality Agreements with Distributors, as well as with manufacturing sites and MAH for distributors markets
·  Analysis of the outcomes of the audits of the Distributors, ensure that efficient action plans are defined, implemented and followed-up until closure by the auditors
·  Annual evaluation of Distributors Quality performance
·  Support to Distributors in case of inspection by local Heath Authorities (GDP, GMP)
·  Qualification of manufacturing sites by distributors when MAHs
·  Contribution to CHC Global or Regional Quality Projects with impact on Distributors (as needed)

Profile:

·  Experience : operational experience “on the field” in quality system management, ideally in the distribution area
·  Soft skills : advanced level in: “Commit to customers”, “Cooperate transversally”, “Business partnering”; advanced networking capabilities (internal & external); easy communication (written & oral); strong interpersonal relationships, team spirit, savvy for working in a multi-cultural & international environment
·  Technical skills : advanced knowledge in GxP (mainly GDP, GMP) regulations, in quality risk analysis/management, quality system management. Advanced knowledge in Pharmacovigilance (GVP) and health-regulated e.g. (Regulatory Affairs, Medical Information) regulations would be additional assets
·  Education : advanced degree in health care/life sciences (such as Pharmacist, Engineer …), additional degree in health care goods quality management
·  Languages : fluent working English & Spanish , any additional language would be an asset

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.