US-MA, Biologics & Plasma Complaints & Data Analytics Manager SR0039325-MZ
Responsible for writing and approving product quality complaints and managing the data analytics and trending assocated with the complaint handling program at Takeda per corporate procedure and regulatory standards including goal setting in-line with corporate strategy and priorities and the GQ road map.
The scope of responsibility encompasses timely management of the complaint processes to comply with corporate procedures, EU and FDA regulations, ISO13485 and other regulatory requirements as applicable. Escalate and participate in resolution of potential product deficiencies for all applicable Takeda products originating from a market complaint. Liaise with Internal Stakeholders, Call Centres and service providers to ensure they support Takedas corporate policies and guidance while aligning with all of the necessary regulations and standards. Serve as the Quality liaison between individuals and business units within or outside the organization regarding matters related to product complaint activities, including risk management, regulatory inspections and complaint handling processes for all applicable products. Identify and drive continuous improvement to ensure a lean and compliant process. Generate complaint metric performance data and act with the wider team to take actions to meet required targets. Act as SME for complaint sections of Annual Product Quality Reviews (APQR s).
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
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