US-MA, QA Manager External Contract Manufacturing Organizations (CMO) SR0030712-MZ
Primary Role This position is responsible for the QA oversight of Contract Manufacturing Organizations (CMO) producing commercial product on behalf of Takeda. The scope of this role includes external Biological CMO s and Contract Test Labs (CTLs). This position is responsible for the management & control of North American contract manufacturers, suppliers and QC laboratories (as applicable) in compliance with applicable standards of GMP & GDP. This role is responsible for ensuring consistency of approach to management of CMO s and CTL s, and for ensuring CMO s/ CTL s are in compliance with the regulatory requirements and the expectations of Takeda. This role will partner closely with External Supply, Technical support, Disposition, QC, Validation, Regulatory, Site compliance lead, OE, to manage CMO s and CTL s, and for ensuring CMO s/ CTL s are in compliance with the regulatory requirements and the expectations of Takeda. Strong collaboration and the ability to effectively work in a matrixed environment is critical to success Responsibilities This position is responsible for management of CMO s / CTL s within Technical Operations according to Takeda, GMP & GDP standards. This role sets direction and strategy to ensure that Takeda s CMO s /CTL s are working to the expectation of Takeda and the required regulations. Sets goals for the function that helps drive strategy execution to enhance and maintain Takedas CMO/ CTL QA oversight in compliance with Takeda global standards. Is responsible for finding solutions to effectively navigate and correct misalignment between different stakeholders both within and outside the operating unit. Provide QA oversight of CMO s and Suppliers. Serve as QA contact/reviewer for quality systems (Deviation, CC, SNC, Protocol/reports, ETC.) QA Reviewer and approver of Master Batch Records Author and owner of CMO Quality Technical Agreements Responsible for proactive monitoring the performance of CMOs & suppliers to ensure that they remain in a state of control are aligned to TOLT metrics/ expectations, and leading the effort to drive improvement Responsible for the development & assessment of quality metrics, KPIs and reports associated with CMO. Responsible to recommend actions as a result of such reviews / reports. Responsible for hosting meetings with external parties and representing Takeda in a professional manner. Management of critical issues and timely resolution, developing solutions to complex problems. Analysis of CMO management processes, partners with OE in the development of quality improvement plans and continuous improvement. Responsible to work with Site compliance lead to ensure CMO are inspection ready. Responsible to support/ lead any technical transfers / projects/ validation/ launch activities related to CMO/ CTL as required Represent QA CMO/ CTL management team with cross functional project teams Responsible to ensure appropriate escalation, communication channels are used to ensure senior management are kept informed of critical issues, as required. Accountable for deployment of Global Quality Standards within the function Supporting external audits Support internal and regulatory agency inspections at Takeda Responsible to ensure on time execution of activities and team timeline adherence Proactively identifies and drives remediation of risks within sphere of influence. Education & Experience Requirements Minimum Bachelor s degree in pharmacy, chemistry, biology or a related discipline. Minimum 7 years experience working in a Quality role in the pharmaceutical industry. Experience in the biotechnology and/or pharmaceutical industry, preferably both Experience in CMO operations Thorough understanding of quality systems, cGMPs, GDPs. Experience with Aseptic/ Sterile Processing and Biological DS manufacturing. Experience leading, training and/or implementing root cause analysis and effective investigation practices High level of professional competence. Preferably demonstrated by objective certification (.e.g.Certified Quality Auditor). Other Requirements Domestic Travel will be required to facilitate robust partnerships and execution. Depending on growth of organization and the primary work location, travel is estimated to be 5-15%.
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