Partner Market Distributors LATAM Quality Business Partner

• Location: Bogotá, Colombia
• Type of role: Permanent / full time

About the job:

Our Team:

Within the Partner Market Distributors unit, supports the Partner Market Distributors LATAM Quality Manager, in order to achieve team's mission:

• Synergize, harmonize & simplify quality processes and WoWs for Distributor Partners & External Wholesales Distributors in the region (LATAM), supporting existing & new business initiatives.
• Ensure coordination & quality oversight of partners and External Wholesale Distributors (EWD), acting in the assigned region (LATAM) on behalf of Sanofi, with the aim to assure that quality processes/ activities are managed by the selected EWDs, in accordance to the split of responsibilities and commitments defined into the relevant Quality Technical Agreements (QTAs).
• Provide support to other country organizations managing one or several EWDs in Export Model, whenever needed.
• Act as Quality focal point for Partner Markets Trade Organization supporting existing & new business initiatives in the assigned region (LATAM).

Main responsibilities:

The Quality Business Partner will support Partner Market Distributors LATAM Quality Manager for a smooth and compliant distribution of Sanofi products in Partner/Export Markets included in the assigned region (LATAM), reducing time to market, applying TRT approach in order to find possible simplification of quality processes.

This will require:

• Act as a focal point with EWDs, operating into the assigned region (LATAM), on Quality related topics. For basic quality topics the Quality Business Partner will be fully independent, keeping the manager in the loop, while for more complex topics a coordination and oversight by the manager will be needed.
• Act as a coordinator, between EWD and Sanofi Legal Entities who are Market Authorization Holders (MAH) of the products distributed by EWD in the Partner Markets/Export countries, in order GMP and GDP responsibilities are fulfilled, reverting to the manager for any complex topic or in case of any support is needed.
• Act as a coordinator, under the oversight of the manager, between EWD and Sanofi manufacturing sites, Global Quality, GBUs or any other global function or entity managing operations linked to the products distributed in the assigned region (LATAM).
• Support quality risk assessment on EWD in the scope, according applicable GOP.
• Whenever is assigned by the manager: organize, and deliver training to EWD on WoWs, tools and processes, as requested.
• Support appropriate maintenance and updating of quality data, records and assigned Sanofi Quality Computerized Systems.
• Ensure the relevant data reconciliations between Sanofi Quality and EWD are properly conducted.
• Support and contribute to the Preparation/Review/Maintenance of Quality and Technical Agreements (with EWD, Sanofi Legal Entities, Service Providers, Manufacturing sites) that are needed in order business contract with EWDs, operating into the assigned region (LATAM), can be fully deployed in compliance with GMP and GDP regulation. Preparation/Review/Maintenance of Quality and Technical Agreements is one of the main responsibilities for the role, the Quality Business Partner is expected to become the first and main actor on this topic, after a first period of induction.
• Support planning and timely quality audits/visits to EWDs, operating into the assigned region (LATAM).
• Collect and reconcile data needed for calculation and monitoring of Key Performance Indicators (KPIs) of quality-distribution performance of EWDs operating into the assigned region (LATAM), and follow up their evolution.
• Support and promote preparation and implementation of agile Ways of Working (WoW) in cooperation with EWDs operating into the assigned region (LATAM), in order to get the best level of compliance and efficiency for quality related processes.
• When designated by the manager, represent Sanofi Partner Market Distributors Quality (LATAM) in project teams and committees.
• Plan and organize Annual Quality Review, performed by EWDs operating into the assigned region (LATAM).
• Organize and attend regular operational meetings with EWDs operating into the assigned region (LATAM), to discuss common quality topics and possible action for simplification and improvement.

Product Technical Complaints (PTC)

• Coordinate/oversee the product technical complaint (PTC) management activities, according to the split of responsibilities in place with EWD, and ensure cases are properly logged and closed on time, reporting to the manager any delay or anomalies detected.
• Review trend analysis and signal detection, as appropriate, referring to the manager.
• When requested by the manager, collaborate with Sanofi Anti-counterfeit coordinator(s) on the management of suspicions of counterfeit/falsified/diverted products received from the assigned markets.

Temperature Excursions Management

• Coordinate/ oversee the Temperature Excursion management activities, according to the split of responsibilities in place with EWD, in order to reduce the time for market disposition (use/destruction) of affected batches, reporting to the manager on regular base.
• Follow-up on CAPAs where applicable to minimize temperature excursions occurrence.

Product-related quality events and alerts

• Whenever delegated by the manager, participate to the coordination meeting in case of product related quality events and alerts, providing support and expertise and following up any assigned action.
• Communicate to the manager any product related quality events originating from EWDs operating into the assigned region (LATAM), in order escalation according to Sanofi requirement can be evaluated.
• In case of recall, in strict contact with the manager, support coordination and follow up of the operational implementation of the recall by EWD, oversee the batch reconciliation, and collect documentation related to the recall process is complete, till destruction certificates.
• When requested by the manager, in case of local theft of stocks, process the case following Sanofi requirements and local regulations in collaboration with the Sanofi Security Manager and the EWD competent function.

Repackaging

• Support coordination for repackaging operations at EWD level, whenever needed for business reason and/or required by local regulation.

Where applicable, administrative release of imported finished products:

• Support, whenever needed, any administrative batch release activity, in order Sanofi products can be made timely available on the market (provide missing information, support assessment of damaged products, etc.).

About you

• Experience: A minimum of 2-3 year of experience in Pharmaceutical Quality.
• Education: Bachelor of Pharmacy Degree or any science/ medical related degree.
• Training evidence on Quality Systems and/or GMP/GDP is preferential.
• Competencies: Compliance mindset together with result-driven mindset.
• Sense of urgency and ability to work under pressure.
• Collaborate effectively with other functions.
• Analytical skills
• Effective communication skills, both in written and verbal form (in English).
• Demonstrates intercultural adaptability and sensitivity.
• High level of accuracy and attention to detail, accountability for corrective actions.
• Technical skills:basic knowledge of GMP/GDP regulation.
• • basic knowledge of Management of Quality Systems (SOPs, records, deviations, CAPA, change control, audit/inspection, annual review, computerized systems).
• • Data Integrity principles.
• • Computer skills must include working with Microsoft 365 and other Sanofi Tools.
• Languages: Spanish language (advanced in written and spoken)
• English language (advanced in written and spoken).

Pursue Progress. Discover Extraordinary.

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