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I further attest that all information I submit in my employment application is true to the best of my knowledge. **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. + 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. **_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_** + Scientific Degree (BSc, MSc) + Minimum 10 years experience in in the pharmaceutical industry including Quality Assurance, combined with a good knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in the region (e.g. familiar with cGMP/GDP, ISO and ICH requirements) + Strong attention to details, ability to review & managing documentation (including transport temperature records, shipping documents, and related GDP documents/ records etc.) + Prior experience managing external GMP/GDP suppliers + Fluent in written and spoken English **Core Competencies / Skills** + Risk-based decision making with strong Quality mindset + Pragmatic operational execution and ownership + Partner management and governance + Clear documentation and inspection readiness discipline + Continuous improvement and problem-solving **Deliver on Takeda Leadership behaviours** + Think Strategically + Inspire others + Deliver priorities + Elevate Capabilities **Takeda Compensation and Benefits Summary:** + Allowances: Commutation, Housing, Overtime Work etc. + Salary Increase: Annually, Bonus Payment: Twice a year + Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45 + Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year) + Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave. + Flexible Work Styles: Flextime, Telework + Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc. **Important Notice concerning working conditions:** + It is possible the job scope may change at the company’s discretion. + It is possible the department and workplace may change at the company’s discretion. **Locations** Osaka, JapanJPN - Tokyo - Global Headquarters **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time