Manager, GDP Export Quality

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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.

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