Company Overview

Role Purpose

Academic Stream

Work experience (in months)

Job Responsibility and key Decisions

External Manufacturing Operations

Coordinate daily operations with CMOs to ensure manufacturing schedule adherence and timely product release.

Track and report production progress, delays, and potential risks to internal stakeholders.

Maintain visibility into inventory levels, production batches, and shipment timelines.

Support the implementation of production plans and capacity forecasts at CMOs.

Performance Monitoring

Monitor key performance indicators KPIs such as OTIF On Time In Full, yield, deviations, and complaints.

Gather and analyze CMO data to support monthly operational reviews and performance scorecards.

Follow up on nonconformance investigations and CAPA implementation with internal teams and CMOs.

Issue Management Coordination

Escalate and help resolve issues related to supply disruptions, deviations, and operational bottlenecks.

Coordinate across functions Quality, Regulatory, Planning, Supply Chain to ensure issue closure.

Participate in root cause analysis and track operational improvements.

Documentation Compliance

Ensure timely and accurate documentation for batch records, deviations, change controls, and quality agreements.

Support audits and inspections related to external manufacturing activities.

Maintain compliance with GMP, regulatory standards, and internal SOPs.

Crossfunctional Support

Collaborate with

Planning Logistics to align delivery timelines

Quality Assurance to support batch review and release

Procurement for contract compliance and CMO engagement

Assist in new product introductions NPIs and technology transfers from an operations standpoint.

Recommend adjustments to production schedules based on capacity or issue resolution.

Support decisionmaking with data and risk insights from CMO operations.

Escalate issues impacting timelines or compliance for leadership attention.