Mgr, External Quality Vaccines - Asia

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This role ensures that manufacturing, testing, packaging, and shipment processes comply with Takeda&#39;s Quality Management System (QMS), current Good Manufacturing Practices (cGMP), and global regulatory requirements. The position requires a strategic focus on quality assurance systems, product technology transfer, and lifecycle management to maintain product quality and compliance across multiple Contract Manufacturing Organizations (CMOs) and global markets.</p><p><b>ACCOUNTABILITIES:  </b></p><p>Provide strategic oversight for quality assurance activities, ensuring alignment with Takeda’s global quality standards. Responsible for day-to-day interactions with contract facilities (CMOs, CTLs, and/or CSPs):</p><ul><li>Conducts/supports investigations on Good Manufacturing Practice (GMP) related issues or observations associated with audits, batch records and complaints.</li><li>Reviews and approves (where applicable) manufacturing and testing deviations and investigations into out-of-specification results.</li><li>Supports timely execution and completeness of change management at interface with CMOs (incl. supplier notification of changes) and of internal Takeda change management</li><li>Reviews and approves batch production records and test records.</li><li>Reviews and approves validation documentations</li><li>Reviews and approves shipment or material transfer request </li><li>Performs batch disposition (Diluent, DS, DP, FDP) as per MAH requirements</li></ul><p>Ensures collaboration with and provides guidance to external manufacturing, project management, supply chain, Manufacturing Science and Technology and CMOs to ensure Q-Systems compliance and manages compliant and timely closure of deviations, CAPA, change controls and interim batch assessment as applicable.</p><p>Executes regular Person in Plant QA oversight and leverages insights to ensure compliance and drive performance and continuous improvement.</p><p>Manages document life cycle (incl. reviews, approval, make-effective and retirement) of GMP   related documents, such as master batch records, risk assessments, etc. according to Takeda QMS requirement.</p><p>In early stages of project, support, review and approve development, technology reports where applicable. Review of submission document ensuring data integrity to source data.</p><p>Provides guidance for technology transfer and validation of manufacturing processes, ensures compliance to Q-systems and regulatory guidances; reviews and approves applicable documents.</p><p>Supports regulatory or Takeda global audits (including product specific inspections at CMOs), VBU Self-Assessment activities and risk mitigation activities identified in Risk Register.</p><p>Maintains culture of teamwork, cooperation and continuous improvement.</p><p>Other duties as assigned.</p><p><b>EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:  </b></p><ul><li>Minimum of Bachelor’s Degree in Pharmacy, Chemistry, Microbiology, or Life Sciences, or equivalent scientific discipline.</li><li>Minimum of 10 years of experience in quality or regulatory compliance within the pharmaceuticals, biologics, or other related industry(ies)</li><li>Experience of cGMPs, ICH and other relevant regulations. A broad-based knowledge of domestic, and general knowledge of international regulations associated with manufacturing, testing and packaging.</li><li>Excellent communication skills both oral and written.</li><li>Experience with supporting product inspections from global Regulatory Authorities.</li><li>Effectively represent Quality Assurance, both internally and externally.</li><li>Experience in routine office software packages and specialized software applications as appropriate.</li><li>Exhibit and promote Takeda Core Competencies.</li></ul><p><b>LICENSES/CERTIFICATIONS:</b></p><ul><li>NA</li></ul><p><b>PHYSICAL DEMANDS: </b></p><ul><li>Manual dexterity required to operate office equipment (i.e. computers, phones, etc.). </li></ul><p><b>TRAVEL REQUIREMENTS:</b></p><ul><li>Some international travel may be required. Approximately 5 – 20%</li></ul><p></p><p style="text-align:inherit"></p><h2><b>Locations</b></h2>IND - Telangana - Virtual<p style="text-align:inherit"></p><h2><b>Worker Type</b></h2>Employee<p style="text-align:inherit"></p><h2><b>Worker Sub-Type</b></h2>Regular<p style="text-align:inherit"></p><h2><b>Time Type</b></h2>Full time