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Job Description

About the role:

• Focuses on operational delivery within clearly defined QMS elements and projects, working under the guidance of the Regional Head CQ Compliance, Systems and Inovation. The role contributes to consistent, compliant, and efficient processes and supports the effective use of key quality systems (eQMS, DMS, LMS) in alignment with GDP/GMP, ICH Q9/Q10, and Takeda standards.
• Serves as a regional subject matter resource for quality systems, compliance processes, and continuous improvement initiatives, supporting consistent implementation of Commercial Quality standards and regulatory requirements.
• Drives operational excellence through proactive compliance monitoring, quality data analysis, system governance support, project leadership, and identification of process improvements that strengthen product quality, patient safety, and inspection readiness. Leads assigned quality system and transformation projects with limited supervision while collaborating effectively with Local Operating Companies (LOCs), Regional Hubs, and Global Quality stakeholders.

How you will contribute:

• Independently coordinates and performs global SOP gap assessments when required, identifies gaps, supports remediation planning, tracks completion and actions, and evaluates effectiveness.
• Serves as regional/local BPO for assigned QMS SOPs, ensuring alignment with global and applicable local regulatory requirements, driving continuous process improvement, and delivering Veeva eQMS training as applicable.
• Provides operational administration and governance for LMS and DMS, including curricula assignment, role mapping, compliance monitoring, document control and lifecycle management; serves as LMS administrator and master trainer for Qualified Trainer and Train-the-Trainer programs; and resolves related IT tickets for DMS/LMS issues, when required.
• Execute lifecycle supplier quality management activities for GxP suppliers/distributors in the region, including audit scheduling, audit execution and CAPA follow up, etc.
• Maintain internal and external quality agreements with other Takeda entities and suppliers/distributors.
• Execute lifecycle customer quality management activities, including customer qualification and bona fide checks, etc.
• Participate the self-inspection when required; Participates in regulatory inspections and internal audits, providing quality system expertise and supporting inspection readiness activities.
• Assist in maintaining the quality risk register, support cross functional risk reviews by preparing materials, capturing outcomes, and tracking assigned actions to closure.
• Collect, validate, and consolidate data for regional quality metrics, prepare quality council materials for review by the Regional Head of CQ Compliance, System & Innovation. Identify basic trends or issues in the data and propose observations or potential areas for follow up.
• Intake product complaints in a timely and compliance manner, manage sample return process when needed, and provide appropriate response to customer/patient when needed.
• Track applicable regulations in the region and coordinate the assessment
• Perform batch disposition and other QA activities as backup for the LOC Quality team at the same location, as required.
• Support or lead defined continuous improvement initiatives (e.g., harmonization of templates, simplification of workflows, enhancements to system usage) as part of cross functional or regional projects.
• Builds collaborative relationships with LOC Quality teams and key stakeholders to support effective QMS execution, provides practical guidance on QMS processes and systems within established procedures and authority, and contributes to communities of practice, training, and knowledge-sharing forums to exchange experience and strengthen expertise.

Minimum Requirements/Qualifications:

• Bachelor's degree in Pharmacy, Life Sciences, Engineering, Quality Management, or related discipline.
• Typically 5–8 years of pharmaceutical, biotechnology, healthcare, or regulated industry quality experience.
• Experience with Commercial Quality, GDP, Quality Systems, Compliance Management, or Quality Operations.
• Experience supporting inspections, audits, supplier quality management, and quality improvement initiatives.
• Experience leading projects or workstreams with limited supervision preferred
• Fluent in English and additional regional/local language(s)

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