Description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s <a href="https://jobs.takeda.com/privacynotice" target="_blank">Privacy Notice</a> and <a href="https://www.takeda.com/terms-and-conditions/" target="_blank">Terms of Use</a>. I further attest that all information I submit in my employment application is true to the best of my knowledge.<h2>Job Description</h2>OBJECTIVES/PURPOSE:<ul><li>Ensure compliant GDP export execution by providing operational Quality oversight and expert guidance across export/transportation activities, maintaining inspection readiness and robust documentation.</li><li>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.</li><li>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.</li></ul><ul><li>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</li></ul>ACCOUNTABILITIES: <ul><li>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.</li><li>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.</li><li>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.</li><li>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.</li><li>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.</li><li>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.</li></ul><ul><li>Ensure compliance with Good Manufacturing Practice and Good Distribution Practice Standards in Singapore</li></ul><ul><li>The company has given authority to the Responsible Person to perform the required activities as per local regulations which include:<ul><li>ensuring that an effective quality system is implemented and maintained that meets GDP standard;</li><li>focusing on the management of authorized activities and the accuracy and quality of records;</li><li>ensuring that initial and continuous training prorammes are implemented and maintained;</li><li>coordinating and promptly performing any recall operations for therapeutic products;</li><li>ensuring that relevant customer complaints are dealt with effectively;</li><li>ensuring that suppliers and customers are legally approved or authorized to enable lawful supply of therapeutic products;</li><li>approving any subcontracted activities which may impact on GDP;</li><li>ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;</li><li>keeping appropriate records of any delegated duties;</li><li>deciding on the final disposition of returned, rejected, recalled or counterfeit products;</li><li>approving any returns to saleable stock;</li><li>ensuring that any additional requirements imposed on certain products by national legislation are adhered to, e.g. controlled drugs.</li></ul></li></ul>CORE ELEMENTS RELATED TO THIS ROLE: <ul><li>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.</li><li>Experience overseeing global export lanes, cold chain distribution, and complex third-party networks.</li><li>Experience with distributor qualification/oversight programs and supplier management.</li><li>Familiarity with global GDP frameworks (e.g., EU GDP guidelines) and practical application across regions.</li><li>Ability to interpret data trends (excursions, lane performance, partner KPIs) to drive risk-based decisions</li></ul>DIMENSIONS AND ASPECTS:Technical/Functional (Line) Expertise<ul><li>Demonstrated experience in GDP Quality within pharmaceutical distribution, logistics, or supply chain (typically 5+ years depending on internal leveling).</li><li>Strong working knowledge of GDP expectations for transportation, outsourced distribution, and quality agreements.</li><li>Experience with deviation management, investigations, CAPA, and audit readiness in a regulated environment.</li><li>Understanding of Commercial Quality requirements, including regional and in-country distribution, controlled substance compliance, supply chain quality, and local quality surveillance (returns, recalls, complaints)</li></ul>Leadership<ul><li>Ability to collaborate and partner well regionally & cross-functionally with Takeda stakeholder groups and RDCs</li><li>Strong communication skills with ability to influence cross-functional stakeholders and external partners.</li><li>Ability to drive change by influence</li></ul>Decision-making and Autonomy<ul><li>Quality approval/endorsement for GDP controls impacting export lanes and distribution models (per Takeda governance).</li><li>Role-specific accountability for Quality oversight of selected distributors and logistics provider</li></ul>Interaction<ul><li>Internal: Supply Chain Governance, Global/Regional Quality, Logistics/Transportation teams, Trade Compliance, Planning, Customer Service, Site QA/QP & RP</li><li>External: 3PLs, freight forwarders, carriers, packaging and monitoring suppliers, contracted distributors.</li></ul>Innovation<ul><li>Understanding of quality and regulatory requirements and trends related to warehousing and distribution across the global regions.</li></ul>EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: <ul><li>Scientific Degree (BSc, MSc)</li><li>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) </li><li>Strong attention to details, ability to review & managing documentation (including transport temperature records, shipping documents, and related GDP documents/ records etc.)</li><li>Prior experience managing external GMP/GDP suppliers</li><li>Fluent in written and spoken English</li></ul>Core Competencies / Skills<ul><li>Risk-based decision making with strong Quality mindset</li><li>Pragmatic operational execution and ownership</li><li>Partner management and governance</li><li>Clear documentation and inspection readiness discipline</li><li>Continuous improvement and problem-solving</li></ul>Deliver on Takeda Leadership behaviours<ul><li>Think Strategically</li><li>Inspire others</li><li>Deliver priorities</li><li>Elevate Capabilities</li></ul>Takeda Compensation and Benefits Summary:<ul><li>Allowances: Commutation, Housing, Overtime Work etc.</li><li>Salary Increase: Annually, Bonus Payment: Twice a year</li><li>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</li><li>Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)</li><li>Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.</li><li>Flexible Work Styles: Flextime, Telework</li><li>Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.</li></ul>Important Notice concerning working conditions:<ul><li>It is possible the job scope may change at the company’s discretion.</li><li>It is possible the department and workplace may change at the company’s discretion.</li></ul><h2>Locations</h2>Osaka, JapanJPN - Tokyo - Global Headquarters<h2>Worker Type</h2>Employee<h2>Worker Sub-Type</h2>Regular<h2>Time Type</h2>Full time

Manager, GDP Export Quality

Description

Takeda

Pipeline