General Medicines
Wo Ideen und Wissenschaft die Gesundheit von morgen gestalten.

Role : Associate Manager - Medical Supply Operations

Location: Hyderabad

Main responsibilities:

The Associate Manager – Medical Supply Operations is accountable for developing and maintaining sustainable operational processes and relationships with Contract Manufacturing Organizations (CMOs) in outsourced medical supply chain activities. Scope includes Externally Sponsored Research (ESR) studies requiring commercial product supply, Managed Access Programs (MAP) product supply for structured programs and single patient requests (when outsourced), Post Trial Access (PTA) product supply management (when outsourced), Humanitarian programs, and associated distribution activities.

Main activities will include (but not limited to):

• Set up and lead outsourced supply management, from supply forecast to product delivery to sponsor locations/investigational sites, including packaging and labelling if applicable, with Medical Operations, Manufacturing & Supply (M&S)/Distribution functional teams, Clinical Supply Chain Operations, and CMC (depending on related medical activities)

• Provide oversight of outsourced supply management for medical operations (e.g., tracking of CMO Key Performance Indicators (KPIs), periodic review of invoices)

• Ensure outsourced supply activities are appropriately built into Sanofi and CMO tools to maintain full tracking/chain of custody, allowing proper and efficient supply/resupply of products to Healthcare Professionals (HCPs)

• Manage Contract Manufacturing Organizations (CMOs) including relationship oversight, performance monitoring, and compliance verification to ensure quality standards and delivery commitments are met

• Proactively identify and manage risks associated with product supply; support internal monthly and quarterly business reviews of programs with key stakeholders

• Ensure compliance with Good Distribution Practice (GDP) and pharmaceutical quality standards throughout the supply chain, including proper storage conditions, temperature control, and chain of custody documentation

• Support audit readiness activities, including internal and external audits related to supply operations, and contribute to timely closure of audit findings

• Support Corrective and Preventive Action (CAPA) management for supply-related deviations and non-conformances; contribute to root cause analysis and implementation of corrective actions

People:

• Report primarily to the Team Lead – Supply Operations, Sanofi Business Operations

• Serve as a key contact for Contract Manufacturing Organizations and coordinate with all internal stakeholders

• Represent the team in supply/manufacturing discussions and communicate appropriately with all internal groups regarding adequate supply and issue resolution

• Serve as primary contact for ad hoc requests from various Business Unit functions and Local/Regional teams for supply forecast data and shipment information

• Build and maintain strong working relationships with Medical Operations, Humanitarian, and PTA teams

• Collaborate effectively with Quality, Clinical Supply Chain Operations (CSCO), country supply chains, and other cross-functional partners

• Actively contribute to a culture of continuous learning by sharing knowledge and best practices within the team

Performance:

• Ensure deliverables meet required timelines, quality targets, and compliance requirements; Contribute to continuous improvement initiatives

• Manage risk and implement back-up plans when needed; investigate root causes when issues arise and recommend remediation plans

• Evaluate the service level provided by CMOs; report data on CMO KPIs and metrics, update and distribute dashboards

• Be solution-oriented, leveraging and adapting existing methods and procedures to resolve moderately complex problems

• Identify and capitalize on opportunities to develop tools, technology, and processes to improve quality and productivity

• Deliver projects as per agreed timelines with agility and high quality

• Track and report on individual delivery milestones and operational KPIs to the Team Lead on a regular cadence

Process:

• Perform supply planning and order management activities including cross-checking orders against forecast

• Support the team with CMO Request for Proposal (RFP) and Technical Conditions completion

• Own program/study demand forecast in Kinaxis; includes data entry, alignment with open orders and financial plan, and communication with local/regional teams to understand demand drivers, identify gaps, and ensure resolution

• Identify, communicate, and escalate root causes of any variations to the program/study forecast

• Support Global Medical Operations with financial planning activities including development of financial plan (3x per year), quarterly landing exercise, and detailed year-end shipment tracking

• Perform monthly shipment reconciliation; includes detailed review of shipments, identification, and resolution of discrepancies

• Work closely with the Global Supply Planning team to ensure supply is secured for all product requests

• Ensure contractual requirements are met including minimum shelf life, packaging updates, etc.

• Partner with Global Medical Operations to manage order backlogs; includes liaising with customer service, problem solving, and interaction with local markets

• Track inventory and replenishment planning at the CMOs

• Ensure proper documentation and record-keeping in compliance with pharmaceutical regulations and internal quality management systems

• Drive best practices for effective operations and contribute toward scaling existing competencies within the team

Stakeholders:

• Medical Product Supply Lead, GBU Medical Programs Governance Leads, Operations Leads, MAP Managers, ESR Managers, Humanitarian Program and PTA Operations Leads

• Demand and Supply Leads, Quality Business Partners

• CSCO, CMC, Quality, Finance, CMO Project Managers and Procurement team

• Other functions as per supply activity needs

• Regulatory Affairs, Distribution Partners, Logistics Providers, and Country Medical Teams

About you

• Experience: 5+ years of experience in clinical/medical supply operations such as demand & supply forecasting and packaging & labelling order management; demonstrated experience in managing vendor relationships and outsourced operations

• Soft skills: Strong administrative and organizational skills; effective communication and stakeholder coordination skills; ability to work in a matrix organization with diverse, global teams; problem-solving mindset with ability to handle complex, ambiguous situations

• Technical skills: Basic MS Office skills, Kinaxis; understanding of pharmaceutical regulations (GDP, GMP) and quality management principles; experience with supply chain management systems and data analytics

• Education: Pharmacy (B.Pharm / M.Pharm), Chemical Engineering / Process Engineering, Biotechnology / Life Sciences, Industrial Engineering / Production Engineering, Supply Chain / Operations Management

• Languages: Excellent knowledge of English language (spoken and written)

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