Partner Market Distributors LATAM Quality Manager

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

About the job

Our Team:
Within the Partner Market Distributors unit, supports the team’s mission inside the assigned region (LATAM), in order to:

• Synergize, harmonize & simplify quality processes and Wo Ws 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:

Support 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.
• Support coordination, 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.
• Support coordination 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).
• Ensure quality risk assessment on EWD in the scope is performed and kept updated, according applicable GOP.
• Whenever is needed, organize, and deliver training to EWD on Wo Ws, tools and processes.
• Ensure relevant quality information and records are timely managed and Sanofi Quality Computerized Systems Data are kept updated.
• Ensure the relevant data reconciliations between Sanofi Quality and EWD are properly conducted.
• Ensure 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.
• Apply Sanofi applicable requirements, in order that quality audits/visits to EWDs, operating into the assigned region (LATAM), are planned and performed whenever needed.
• Support any audit/inspection at Sanofi or EWD with potential impact on Sanofi products distributed in the assigned region (LATAM).
• Apply Key Performance Indicators (KPIs) to ensure monitoring of quality-distribution performance of EWDs operating into the assigned region (LATAM), and follow up their evolution.
• Implement agile Ways of Working (Wo W) 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.
• Represent Sanofi Quality (MCCQ) in project teams and committees related to Partner/Export Markets in the assigned region (LATAM).
• Ensure Annual Quality Review is performed by EWDs operating into the assigned region (LATAM).
• Ensure regular operational meetings with EWDs operating into the assigned region (LATAM) are in place, 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.
• Review trend analysis and signal detection, as appropriate.
• Collaborate with Sanofi Anti-counterfeit coordinator(s) on the management of suspicions of counterfeit/falsified/diverted products received from the assigned markets. Where applicable, collaborate on notifications to Health Authorities.

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.
• Follow-up on CAPAs where applicable to minimize temperature excursions occurrence.

Product-related quality events and alerts

• Coordinate/ oversee the product related quality events and alerts, in order Sanofi requirements are fulfilled.
• Escalate any product related quality events originating from EWDs operating into the assigned region (LATAM), as per Sanofi requirement.
• Ensure cooperation with Global Alert Leaders / Global Quality Alert Team on globally launched product alerts impacting markets inside the assigned region (LATAM).
• In case of recall, co-ordinate, follow up of the operational implementation of the recall by EWD, oversee the batch reconciliation, and ensure documentation related to the recall process is complete including destruction certificates.
• 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 and ensure 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 3 to 5 years of experience in Pharmaceutical Quality, with a role requiring the knowledge and application of GMP/GDP regulation.
• Education: Bachelor of Pharmacy Degree or any science/ medical related degree.
• Master's degree in quality systems or GMP/GDP is preferential
• Soft skills: Planning and organizational skills,
• Influence and negotiation skills.
• Compliance mindset together with result-driven mindset.
• Thoughtful Risk Taking capabilities.
• Sense of urgency and ability to work under pressure.
• Ability to work in autonomy, feeling empowered to take decision when needed, with the support of her/his manager and all other functions.
• Collaborate effectively with other functions.
• Analytical skills
• Utilizes effective interpersonal 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: GMP/GDP regulation.
• Management of Quality Systems (SOPs, records, deviations, CAPA, change control, audit/inspection, annual review, computerized systems).
• Quality Risk Management.
• 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.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

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