Head of Product Quality & Lifecycle Management, Biologics Operating Unit (Sr Director)

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Job Description

OBJECTIVES/PURPOSE

The Head of Biologics Product Quality & Lifecycle Management (Sr Director) is accountable for the end-to-end product and process quality from development through the commercial lifecycle of all Biologics products.  Leading & developing a team of Product Quality Leads (PQLs), and the Analytical Sciences function, she/he ensures proactive mitigation of product quality risks and compliance with GMP expectations.  This role serves as the key quality liaison between Biologics Business Unit senior management and Global Quality, Regulatory Affairs, and Operations, fostering seamless communication and decisive actions related to product quality.

• Strategic Product Leadership: Defines and drives strategic product priorities across the product lifecycle, aligned with compliance and business imperatives through governance forums.
• Strategic Stakeholder Engagement: Engages with a wide set of internal and external stakeholders to gather insights, analyze complex data, and provide strategic recommendations to address operational, compliance, and regulatory challenges. Collaborates with stakeholders at a senior level to drive innovation, continuous improvement, and ensure alignment with quality objectives and overarching business strategy and budget.

Key Responsibilities

• Organizational: Helps develops, defines and executes the product quality strategies within the Bio OpU. Ensures support for long-term quality objectives, regulatory submissions/approvals, and product quality reviews. Maintains alignments across supporting Global Quality (GQ) and Biologics functions involved in the oversight of Biologics products. Creates, leads and develops a team of PQLs, and Analytical Sciences functions.
• Quality Governance: Drives quality accountabilities and provides expertise in product governance, including the Product Operations Team (POT), and Global Product Teams. Accountable for the seamless onboarding of new product development/clinical programs and supporting related business development programs as appropriate.
• Process Improvement:  Provides quality guidance for process performance monitoring, trend assessments and continuous process improvements. Manages product issues across the OpU, including contamination control strategy and works with sites on major / critical investigations, deviation trends, customer complaints, ensures investigation to identify root cause (s) and ensures appropriate improvement plans in place.
• Product Lifecycle Management: Provides strategic and cohesive oversight, direction, and leadership for analytical method lifecycle management (LCM), including analytical methods, analytical method transfer, optimization, and testing aspects for Takeda’s commercial Biologics product portfolio.
• Business Strategy & Innovation: Defines and drives the development and execution of product quality strategies and innovation based on business needs and product lifecycle across the Biologics portfolio. Engages with a wide set of internal and external stakeholders to gather insights, analyze complex data, and provide strategic recommendations to address operational, compliance, and regulatory challenges. Collaborates with stakeholders at a senior level to drive innovation, and ensure alignment with quality objectives and overarching business strategy and budget.

Accountability

• Team Leadership and Development: Lead, mentor, and develop a high-performing team of quality professionals, providing guidance, support, and opportunities for growth. Foster a culture of collaboration, innovation,