仕事内容 | 【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.
・As deputy RP responsible Eligible to perform all the duties and have all rights applicable to the Deputy Responsible Person in Singapore as per HSA requirements
【ACCOUNTABILITIES】
・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
・The company has given authority to the Responsible Person to perform the required activities as per local regulations which include:
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 prorammes 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.
【CORE ELEMENTS RELATED TO THIS ROLE】
・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
【DIMENSIONS AND ASPECTS】
◎Technical/Functional (Line) Expertise
・Demonstrated experience in GDP Quality within pharmaceutical distribution, logistics, or supply chain (typically 5+ years depending on internal leveling).
・Strong working knowledge of GDP expectations for transportation, outsourced distribution, and quality agreements.
・Experience with deviation management, investigations, CAPA, and audit readiness in a regulated environment.
・Understanding of Commercial Quality requirements, including regional and in-country distribution, controlled substance compliance, supply chain quality, and local quality surveillance (returns, recalls, complaints)
◎Leadership
・Ability to collaborate and partner well regionally & cross-functionally with Takeda stakeholder groups and RDCs
・Strong communication skills with ability to influence cross-functional stakeholders and external partners.
・Ability to drive change by influence
◎Decision-making and Autonomy
・Quality approval/endorsement for GDP controls impacting export lanes and distribution models (per Takeda governance).
・Role-specific accountability for Quality oversight of selected distributors and logistics provider
◎Interaction
・Internal: Supply Chain Governance, Global/Regional Quality, Logistics/Transportation teams, Trade Compliance, Planning, Customer Service, Site QA/QP & RP
・External: 3PLs, freight forwarders, carriers, packaging and monitoring suppliers, contracted distributors.
◎Innovation
・Understanding of quality and regulatory requirements and trends related to warehousing and distribution across the global regions.
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