Cell Therapy Quality - Product Lead
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Cell Therapy Quality - Product LeadApply Now
Design Quality strategies and provide GMP quality/compliance guidance to internal stakeholders by serving as Quality lead on Cell Therapy program development teams.
Influence and drive decisions across product teams and stakeholders during clinical development through commercialization.
Provide leadership when significant compliance or safety risks arise in the manufacturing, testing, and distribution of Takeda Cell Therapy products to ensure immediate protection of patient safety and compliance with current regulations and company standards
Partner with relevant subject-matter experts and teams to highlight potential quality issues during development, process transfer, GMP manufacturing and testing and identify/execute strategies to effectively mitigate and/or manage
Ensure Quality oversight of technical/manufacturing changes and lead end-to-end related change control management, working cross functionally to ensure compliant and timely completion
Minimize risks to patients and operations through early detection of quality issues by proactively monitoring & trending product data
Develop and implement quality elements needed to facilitate launches of new Cell Therapy products and collaborate with key stakeholders on the overall control strategy (e.g., in-process, release, stability testing and respective acceptance criteria)
Lead Quality activities related to commercial launch of assigned programs and act as the main Quality contact between R&D and commercial manufacturing site
Continuously build product & process knowledge; maintain oversight on process capability through data trending and statistical analysis of critical variables; collaborate with technical/scientific personnel to ensure processes are robust, in a continued state of validation and are continuously improving
Partner in Regulatory strategy development, revising and/or approving documents such as supplements/variations, renewals, CMC maintenance reports, annual reports and assure consistency of regulatory filings for assigned product(s)
Support product and site inspections and audits from Regulatory Authorities and other organizations
In partnership with technical SMEs, review trended product data and assess impact of process changes and effectiveness of CAPAs and change controls on product quality
Review and approve relevant risk assessments, change controls, deviations, investigations and associated CAPAs
Ensures effective stakeholder management across the product lifecycle with effective and robust communication to facilitate knowledge management and continuous improvement
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelor’s Degree in Chemistry, Biology, Engineering or related field. Masters preferred.
Minimum of 15 years of increasing responsibility and experience in the global pharmaceutical industry, with at least 8 years of Quality/cGMP Compliance experience.
Specific experience in cell and/or gene therapy product manufacturing, pharmaceutical development, and advanced therapy medicinal products.
Experience product quality management from development through product commercialization is essential
Experience working in an internal biopharmaceutical development/production environment.
Time TypeFull time
Job ID R0031712