Manager, GDP Export Quality

Job Description Objectives / Purpose

• Ensure compliant GDP export execution by providing operational Quality oversight and expert guidance across export/transportation activities, maintaining inspection readiness and robust documentation.
• Lead risk and quality event management by identifying and mitigating distribution risks, translating QMS requirements into practice, and driving deviations/CAPA and change control for export lanes, providers, and processes.
• Oversee external partners (especially central-contracted distributors) through qualification and performance monitoring, effective Quality Agreements, and strong cross-functional collaboration across Supply Chain, Site Quality, LOC Quality, and project teams.

• Provide operational GDP Quality oversight for export execution across shipment preparation, handover, transportation, and delivery, ensuring activities meet applicable GDP regulations and Takeda Quality standards.
• Serve as the Quality SME for export and transportation (including cold chain where applicable), advising on packaging/ship-to configurations, monitoring strategy, handling instructions, security controls, and lane suitability.
• Lead risk identification, assessment, and mitigation for export distribution (lanes, carriers, forwarders, 3PLs, distributors), ensuring risks are documented, owned, controlled, and periodically reviewed in line with governance expectations.
• Oversee deviation/event management for export distribution (e.g., temperature excursions, delays, damages, misroutes, seal breaches), ensuring timely triage, investigation support, documented Quality impact assessment, and effective CAPA implementation.
• Drive change control for export GDP scope, ensuring changes to lanes, logistics partners, distributors, packaging solutions, and monitoring processes are assessed and implemented with appropriate Quality review, evidence, and approvals.
• Deliver GDP oversight of contracted distributors (central Takeda contracts), including distributor qualification/onboarding, Quality Agreement content and maintenance, periodic performance review, escalation management, and ensuring continued compliance with Takeda expectations.

• Ensure compliance with Good Manufacturing Practice and Good Distribution Practice Standards in Singapore.

• Ensuring that an effective quality system is implemented and maintained that meets GDP standard.
• Focusing on the management of authorized activities and the accuracy and quality of records.
• Ensuring that initial and continuous training programmes are implemented and maintained.
• Coordinating and promptly performing any recall operations for therapeutic products.
• Ensuring that relevant customer complaints are dealt with effectively.
• Ensuring that suppliers and customers are legally approved or authorized to enable lawful supply of therapeutic products.
• Approving any subcontracted activities which may impact on GDP.
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
• Keeping appropriate records of any delegated duties.
• Deciding on the final disposition of returned, rejected, recalled or counterfeit products.
• Approving any returns to saleable stock.
• Ensuring that any additional requirements imposed on certain products by national legislation are adhered to, e.g. controlled drugs.

• Maintain strong cross-functional collaboration with Global Supply Chain, Trade Compliance, Site Quality Organizations, GDC/RDC-related LOC Quality, and Takeda project teams to resolve issues, support initiatives, and ensure aligned decision-making.
• Experience overseeing global export lanes, cold chain distribution, and complex third-party networks.
• Experience with distributor qualification/oversight programs and supplier management.
• Familiarity with global GDP frameworks (e.g., EU GDP guidelines) and practical application across regions.
• Ability to interpret data trends (excursions, lane performance, partner KPIs) to drive risk-based decisions.

• Demonstrated…