The purpose of this role is to ensure consistent global leadership for key Quality processes, including but not limited to Corrective and Preventive Action (CAPA), Deviations, Quality Improvement Programs (QIP),and integration related activities. The Quality Systems Lead / Business Process Owner (BPO) is accountable for the development, deployment, maintenance, and continuous improvement of the assigned processes, including procedures, practices, and IT workflows. The BPO will ensure that process requirements are effectively deployed in interdependent processes, projects, and/or initiatives. This will include serving as primary decision-maker and key point of contact for assigned processes. This may also involve serving as Subject Matter Expert (SME) as well as Program, Project, or Workstream Lead on cross-functional teams.
60%-Develop, Deploy, and Maintain Assigned Processes
Maintain global processes, procedures, and training materials in compliance with Global cGMP requirements, Takeda Global Quality Standards (GQS), and Takeda’s QMS principles of simplicity, scalability, and risk-based decision-making.
Support sites and functions teams during regulatory inspections or customer audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.
Support deployment of global process by close cooperation with site execution leads. Provide training, support and coaching as required.
Define Community of Practice (COP), including roles, operating mechanisms, and communication strategies
Liaise with Quality Leadership Team and other functional leaders to identify and empower COP members.
Ensure that training and access are provided at defined levels for all COP members.
Provide leadership, coaching, and training for COP. This includes both the technical processes and the behaviors necessary to optimize process execution
Define process monitoring methods, including data collection and analysis, metrics and associated targets, and reporting mechanisms. This includes both product quality and process effectiveness aspects.
Collaborate with other BPOs and SMEs to drive optimal execution of assigned process across Takeda and external partners.
Support or manage high-priority, cross-functional events as directed by Takeda Quality
Maintains global expertise through ongoing training and participation in industry forums
30%-Continuous Process Improvement
Utilize metrics and COP operating mechanisms to identify and prioritize process improvements
Lead efforts to scope, plan, and implement process improvements. This will include accountability for ensuring sustainable improvements; and may include process, procedure, systems, and training material changes as well as use of appropriate change management and communication principles.
Ensure continuity of process and support systems through major initiatives, including but not limited to integration, divestiture, or reorganization. This will involve serving on/leading program teams or subteams, managing interim state of operations, and ensuring establishment of defined future state of processes as applicable.
Provide data and input to drive other continuous improvement efforts across the enterprise as applicable. This may include priority and timing collaboration with other BPOs.
Maintain awareness of Continuous Improvement Culture across Takeda, including obtaining/sponsoring Belt certification as directed.
10%-IT System Business Owner
Support development, approval, and execution of business case approval for improvement projects.
Serve on systems project teams and committees to ensure that all system issues and opportunities are accommodated in a timely, effective, and Right First Time manner.
Education & Experience Requirements
Bachelors’ degree in a science or engineering related field
5-10 years of experience in Pharmaceutical / Biotechnology industry with demonstrated Quality Systems responsibilities
Successful experience in serving on and leading global cross-functional teams, including internal and external stakeholders
Demonstrated experience in cross-functional development, improvement, and/or use of Change Control, CAPA, Deviations, Integration, or QIP processes and associated IT systems on a local and global level.
Masters’ Degree in Science, Business or Quality Assurance
Six Sigma Green/Black Belt, ASQ Quality Manager and/or similar certification
Experience with Medical Devices, Biologics, Blood Products and small Molecules
Demonstrated success in project management or leadership (including accountability for scope, schedule, and/or resources) within a matrix environment
Experience with global integration or divestiture of assets
Experience with execution or management of Quality processes across internal and third-party manufacturing networks.
Travel likely (including international), up to 25%
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Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.