Title: Manager - External Manufacturing Org
Roles and Responsibilites
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.
Other Roles
1. 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.
2. 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.
3. 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.
Qualification Required
- Education- MBA or related field
- Experience- Atleast 10 years experience is required.
- Pharma experience is mandatory with regulated market experience.
Head Office, Ahmedabad, GJ, IN, 380054