Manager, GDP Export Quality

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Job Description

OBJECTIVES/PURPOSE:

• Ensure compliant GDP export executionby providing operational Quality oversight and expert guidance across export/transportation activities maintaining inspection readiness and robust documentation.
• Lead risk and quality event managementby 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 executionacross 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 mitigationfor 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 collaborationwith 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 overseeingglobal 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 inGDP Qualitywithin pharmaceutical distribution logistics or supply chain (typically 5 years depending on internal leveling).
• Strong working knowledge of GDP expectations fortransportationoutsourced distribution andquality 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 companys discretion.

• It is possible the department and workplace may change at the companys discretion.

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