US-MA, Associate Director PIER Investigations SR0031234-MZ
The AD of Investigations is responsible for leading the group that provides support to internal drug substance manufacturing operations at the Lexington site for deviations, EM excursions, and instrument OOTs. The AD is the point of contact for Manufacturing investigations for specific plant(s) within the Lexington site. The key support services, deliverables, and capabilities within this function include: Management of deviation, EM and OOT closure to support product disposition and compliance Preparation and presentation of deviations during regulatory inspections and audits Coaching/training for the plant investigators Subject matter expertise (SME) for deviation investigation SME for business processes for deviations, EM excursions and OOTs Implementation and improvement of LDI system, including development and monitoring of metrics intended to drive business process improvements Collaboration with peers to drive the alignment of the Investigations teams activities across plants Liaise between manufacturing and Center functions as applicable The AD is responsible for driving the organization towards a culture of safety, innovation, collaboration, best practice, accountability, and efficiency. The primary objective is to ensure consistent methodologies are applied to deviation/EM excursion/OOT management, including compliance with regulatory requirements and Takeda policies/procedures, timely closure and identification of appropriate corrective actions. 40% Manage and Develop Staff- through direct supervision of investigators and management of supervisors of investigators Motivate and support the career development and technical expertise of staff, and communicate company policies/goals/strategies/business results. Anticipate resource requirements, delegate appropriately, and assure staff members are productive and work is focused / aligned with company and departmental objectives Engage in proactive measures to promote and foster a positive safety culture to ensure zero incidents, injuries, and the protection of people, property and the environment through communications, review of EHS performance metrics and incident reports Champion self-initiated projects and drive area under their control within the context of functional area priorities Effectively communicate ideas, project goals, and results Foster teamwork and drive project/process improvement 30% Deviation Investigation Management Analyze investigations and ensure: quality of written records; technically sound root cause analysis and product impact assessment; identification of appropriate corrective actions; timely closure Harmonize content expectations and writing styles across plants within the Lexington site via collaboration with peers, QA contacts and BPO function Maintain knowledge of current industry best practices related to root cause analysis and human performance; promote implementation at Takeda as applicable Lead cross-functional teams for high-severity/highly complex investigations as necessary 10% Inspection Readiness and Support Ensure deviation records are compliant and in a state of inspection readiness at all times Prepare SMEs for and present investigations during regulatory inspections and audits 10% LDI System Support Support the implementation and improvement of the Work System at Lexington manufacturing site including reporting and evaluation of metrics 10% Training Maintain organizational capability to train team members on quality system(s) and business processes at the plant Education and Experience Requirements BS/MS Degree in Science or Engineering with 10+ years of relevant experience Prior experience as a manager of people is required; experience managing people managers is strongly preferred Proven record of cross-functional technical leadership, including ability to influence, motivate, and drive technical rigor Knowledge of cGMP and other regulatory requirements related to manufacturing of biologics Key Skills, Abilities, and Competencies Strong technical leadership and experience in commercial biopharmaceutical manufacturing in the areas of cell culture and/or purification, engineering or validation. Must possess knowledge of cGMP, commercial operations and root cause analysis tools Excellent verbal and written communication skills, including demonstrated ability to effectively present to senior management and regulatory inspectors Organizational effectiveness and employee development focus Customer service oriented Ability to foster environment of learning and continuous improvement Complexity and Problem Solving Capable of making technically sound and compliant recommendations regarding root cause analysis and product impact. Internal and External Contacts Manufacturing TS Operations (Floor Support) Process Development Technical Services Quality Assurance Quality Control Regulatory Affairs Facilities & Engineering Validation Materials Management Regulatory External vendors
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