Head of Product Quality & Lifecycle Management, Biologics Operating Unit

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Job Description

OBJECTIVES/PURPOSE

The Head of Biologics Product Quality & Lifecycle Management 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, and continuous learning within the team to drive excellence in quality performance and ensure alignment with organizational goals.
• Budget and Financial Oversight: Owner of budget planning, optimization and management for the Product Quality Biologics function, ensuring alignment with strategic quality objectives and efficient resource allocation. Identify potential cost-saving opportunities within the product life cycle management teams.
• Innovation and Transformation: Drive innovation and transformation in product quality related processes and systems to ensure continuous improvement and operational excellence by enhancing efficiency within quality and commercial operations. Support Biologics quality units to drive implementation of new technologies aimed at diving increased efficiency such as Process Analytical technology (PAT).  Drive the  implementation of data and digital tools within the quality units across the biologics Operating unit.
• Risk Management: Drive proactive risk management strategies to anticipate and mitigate quality risks across the Biologics product lifecycle.
• Quality Strategy: Serve as the quality strategic representative for Biologics product teams), translating global GQ & Biologics strategy into operational quality strategy for execution by relevant function.
• Global Governance Representation: Represent Biologics Quality in Global governance and commercial teams, ensuring alignment and strategic decision-making with all stakeholders.
• Quality Expertise: Provide technical quality expertise in compliance with global regulatory requirements and internal policies for Product Development (eg. Qbd), Product Characterization, Product Specifications, Method/Assay Development & Validation, and Comparability assessments for tech transfers and for continuous process monitoring (CPV, trending) as appropriate.  Act as designee at QAM meetings for OpU Head of Quality as required.
• Regulatory Compliance: Accountable for quality review & approval of regulatory submissions (filings, annual reports, responses to questions, progress reports) to ensure alignment with operational and quality strategies in accordance with cGMP requirements.
• Cross-Functional Leadership: Lead product quality-related cross-functional teams (e.g., POM quality subteam) to ensure product performance oversight and develop strategic/tactical quality input for sustainable compliant products with continuity of supply.
• Incident Escalation Direction: Provide strategic direction for the Incident Escalation process to address product quality issues effectively.
• Product Launch Oversight: Lead quality oversight during product launch and develop Biologics quality strategy for the Global product launch team.
• Supply Chain Strategy: Lead Quality input to establish preferred Supply Chain architecture, collaborating with stakeholders to enhance product, process, and supply chain strategies, and define key product launch considerations, attributes, and profiles for products nearing commercialization.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Capability to recognize the need for expert advice; asks for and uses input accordingly
• Provide global technical support for analytical methods and process related quality aspects for Biologics
• Role is technical in nature and will engage in technical discussions and activities that span the various technology platforms for the company, with a focus on the quality aspects of equipment and process validation and engineering.
• Application of robust Quality Risk Management principles

Leadership

• Develop and communicate convincing Biologics Manufacturing business cases for improvement and proactive management of processes and product quality that motivate stakeholders to take action
• Cultivate a broad network of relationships throughout Takeda, with affiliates and alliance partners, in the industry and area of expertise
• Exercise independent judgment to determine most appropriate course of action including technique and method selection, protocol and study design and execution, in-depth data analysis, factor evaluation and use of established practices and procedures for a variety of problems of broad scope and complexity, in alignment with organizational objectives
• Exemplify and champion critical thinking in identifying and implementing highly innovative and effective solutions and strategies, leveraging established practices and procedures for a broad range of problems to sustain company products, objectives and priorities

Decision-making and Autonomy

• Create functional strategies and goals that are closely aligned with Takeda’s objectives and develop metrics to track and assess performance
• Develop concise, strategic plans based on a clear understanding of the organization’s strengths, weaknesses, opportunities and threats
• Decision making with regard to area of responsibility in established cross-functional teams

Interaction

• Frequently presents challenging issues and results at department and cross-functional gatherings, and project team meetings. May act as organizational representative and present at external meetings or publishes in peer-reviewed journals
• Conducts briefings and technical meetings for senior management and customer representatives.  Interacts with equivalent level managers concerning matters of significance to the company
• Achieves results by managing the right combination of diverse people, resources, and processes

Innovation

• Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of Biologics Manufacturing project plans, and considering state-of-the-art scientific and industry practice
• Works on abstract problems across functional areas of the business.  Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables.  Expected to escalate issues as appropriate in a timely fashion

Complexity

• Understands differences in practices across organizations or countries, and balances local demands and perspectives with global strategies
• Creates an environment that promotes information exchange and the open and honest expression of opinions, thoughts and beliefs
• Ability to define problems and draw conclusions or provide recommendations based on limited data, as it relates to technical, regulatory/compliance and operational issues
• Monitors all operations and project related activities and takes action as needed to ensure timely delivery of goals and to meet KPIs
• Designs and implements scientifically sound, creative and innovative solutions to a variety of problems of broad scope and complexity to support company products in alignment with organizational objectives

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• 15+ years professional & leadership experience in a similar role in the field of Technical Operations, Process Management, Manufacturing, Quality within the pharmaceutical industry
• Background in/knowledge of Biologics derived medicinal product manufacturing is essential
• Experienced people manager, working in a matrix organization, enabling to connect teams with each other
• Very successful track record of change management projects and processes
• Broad knowledge and experience within the GMP environment, and regulatory affairs
• Thorough understanding of applicable regulations and guidance documents pertaining to manufacture and control of Biologics derived medicinal products.

Excellent communication skills, verbal and written communication skills

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

U.S. Base Salary Range:

$208,200.00 - $327,140.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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