Vaccine External Supply Quality Lead, Asia

3 weeks ago

Gurgaon, Haryana, India Takeda Full time

About the Role:

As a key member of the Takeda team, you will be responsible for creating and leading an appropriate Quality oversight organization and designing, establishing, and continuously improving a Quality Management System that ensures consistency in achieving process and product quality and compliance across multiple local Contract Organizations (CMOs, Contract Testing Organization, Distribution Organization) for clinical trial and commercial material.

Key Responsibilities:

  • Accountable and responsible for creating and leading an appropriate Quality oversight organization and designing, establishing, and continuously improving a Quality Management System.
  • Responsible for critical quality and compliance decisions regarding locally manufactured, tested vaccine products for local and global distribution.
  • Collaborates closely with internal teams such as Vaccine Operations, Regulatory Affairs, and Legal teams.
  • Negotiates contracts and establishes policies with external contract organizations.
  • Plans and manages functional budget, including budget for work packages/activities at contract organization.
  • Provides strategic leadership and has accountability for external manufacturing & testing quality oversight of vaccines in the Asia region.
  • Provides guidance on quality considerations and supports negotiation of contract terms across multiple sources of supply.
  • Establishes and maintains contracts/policies/procedures.
  • Makes critical quality and compliance decisions regarding vaccine process & products manufactured/tested at Asia CMOs, including clinical trial material, commercial material, and starting (cell banks and virus banks) material.
  • Drives collaboration with external partners in Asia to assure consistency in achieving process/product quality and compliance across multiple Contract Manufacturing Organizations (CMOs).
  • Ensures product supply, compliance with local regulatory requirements, and global vaccines dossier in partnership with local cross-functional internal partners for external supply, Regulatory Affairs, project management, process development, and VBU Quality and Global Quality and regulators.
  • Builds and leads the local QA team, creating, developing, deploying, and maintaining an adequate and effective QMS system.
  • Ensures timely execution of Quality Assurance and Quality Operations tasks and appropriate cGMP oversight to ensure successful tech transfer and subsequent commercial supply continuation.
  • Shapes the long-term strategy and framework for vaccines External Supplier Quality in the region, including day-to-day operations such as review and approval of batch records, investigations, documents, change control, submission of batch-specific documents to local authorities, batch disposition, process, and analytical method performance monitoring and trending.
  • Establishes, maintains, and monitors supplier files, including Quality Agreements with CMOs and their suppliers.
  • Plans, creates, and controls the department budget and budget-related to CMO quality work-packages, aligns financial planning with strategic global VBU quality objectives and budget plan with Vaccines Operations partners.
  • Acts as the key-quality lead for CMO Site Quality Head and Senior Quality management team regarding vaccine operations executed at local CMOs and as the key quality partner for internal VBU and Takeda functions regarding vaccine manufacturing, testing, and supply in Asia, for Pan American Health Organization countries, and for World Health Organization.
  • Ensures cGMP requirements, Takeda expectations, and global dossier compliance are fulfilled for activities at contract facilities.
  • Evaluates, defines, and utilizes digital and automation tools to continuously drive operational excellence in collaboration with global functions.
  • Establishes, maintains, and continuously improves system & processes to manage CMO change controls and investigations for issues associated with audits, manufacturing/testing events, and complaints, ensuring appropriate actions are implemented and aligned with VBU global product life cycle management and the company's strategic objectives.
  • Establishes system & processes for manufacturing process and analytical method transfers from Takeda internal sites (or Takeda external partners) to local CMO.
  • Provides quality guidance and oversight for specific tech transfers and ensures execution according to plans and protocols.
  • Designs an appropriate oversight organization model that includes planning of resources to ensure regular representation of QA staff at CMO plant (Person In Plant), packaging site, laboratory, and warehouse/distribution center and leveraging insights to drive performance, strategic decision-making, quality risk management, and continuous improvement.
  • Organizes and participates in internal audits. Serves as an expert and key person for regulatory submissions.
  • Enables vaccines national batch release through strong collaboration with local regulator and national control laboratories.
  • Establishes and cascades functional goals based on GQ, VQ, and VBU strategy and goals and development plans for the team, focusing on continuous improvement and Takeda's Leadership Behaviors.
  • Develops and establishes appropriate operating mechanisms with CMOs and with internal interface functions such as joint QCouncils, QRisk Registers, and KPI reviews to manage CMO performance and risk, aligning with the company's strategic objectives and long-term vision.
  • This position interacts frequently with:
    • VBU Quality and VO leaders
    • VBU QA team
    • GMS QA and QC
    • LOC QA
    • RA-CMC (VBU)
    • Local RA
    • VBU Manufacturing Science Quality
    • Global Pathogen Safety Team
    • Corporate alliance partners and Takeda distribution partners
    • Contract Manufacturing Organizations and Contract Testing Facilities
    • Supply management
    • Product Development, CMC Team Leaders
    • National Control Laboratory and country MoHs

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