External Manufacturing Organization (CMO) Coordination

Role & responsibilities

1. Demand Forecasting & Supply Planning

• Collaborate with global commercial teams to collect, consolidate, and validate monthly and long-term demand forecasts for EU and US markets.
• Translate market demand into supply plans for external manufacturing partners (CMOs) while factoring in lead times, batch sizes, MOQs, and regulatory constraints.
• Ensure alignment between supply capabilities and sales forecast to meet customer service levels and avoid stock-outs or excess inventory.

2. CMO Coordination

• Technology Transfer Support: Participate in coordination of scale-up, validation, and technology transfer to external sites. 
• Communicate monthly and rolling production schedules to CMOs, ensuring timely manufacturing and dispatch of finished goods.
• Monitor and track CMO production milestones, highlighting and resolving delays, bottlenecks, or deviations from plan.
• Coordinate between CMOs and internal teams for timely availability of materials (API, packaging components) required for production.

3. Inventory & Logistics Management

• Maintain optimal inventory levels across internal warehouses and at CMOs to ensure uninterrupted supply and regulatory compliance.
• Liaise with distribution and logistics teams to manage dispatches from CMOs to domestic or international destinations.
• Track shipments, ensure documentation readiness (COA, COE, batch records), and coordinate with regulatory and QA for release.

4. Regulatory & Quality Alignment

• Ensure compliance with EU-GMP, USFDA, and global regulatory requirements at all stages of CMO production and supply chain.
• Coordinate with Quality Assurance for batch release, deviation handling, CAPA tracking, and quality agreements with CMOs.
• Support audit readiness for EU/US inspections and customer audits at external sites.

5. Cross-Functional Collaboration

• Act as the operational bridge between Commercial, QA, Regulatory, Manufacturing, Procurement, and the CMO partners.
• Lead S&OP discussions from the external manufacturing supply side, sharing risk-based insights on supply gaps or delays.

6. KPI Monitoring & Reporting

• Monitor and report on key supply chain performance indicators including OTIF (On Time In Full), forecast accuracy, inventory turns, production adherence, and lead time compliance.
• Prepare weekly/monthly dashboards for internal reviews and global stakeholder communication.

7. Change & Risk Management

• Manage change control processes in coordination with Regulatory and QA for site, pack, or process-related changes at CMOs.
• Identify and mitigate risks related to capacity constraints, regulatory barriers, quality issues, or supply disruptions.

Preferred candidate profile

Candidate must have experience to work with CMO and international client handling.