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Job Description

About the role:

The PQL – Biologics and Gene Therapy, will provide global quality oversight of Takeda’ products, across the assigned product technology platform, from late clinical development phase through commercialization and throughout lifecycle. They will be part of a team of Product Quality Leads, and be involved in development of strategy to proactively minimize product quality risks during product development, technology transfer, and commercial operations. The PQL is the quality liaison between Regulatory Affairs and Operations to ensure compliance of GMP operations in support of assigned programs. The role enables efficient communication and decision making related to the quality aspects across the Global Product Teams, manufacturing sites and global functions. They are the designated accountable representative for Quality decision making at a strategic level, in consultation with business partners.

• Primary responsibility for the strategic quality oversight of the company’s global commercial Biologics product portfolio.

• PQL (Associate Director) is responsible for the more complex products (market, site) in the Global product portfolio.

• Supports the development and execution of product strategies based on business needs and product lifecycle for both commercial products and products at late stage development.

• Accountable for supporting long-term qualityobjectives for the global product portfolio, and for supporting ongoing continuous improvement.

Through the relevant governance forums, defines product priorities in alignment with compliance and business requirements, and ensures execution and implementation through the approval of project business cases, ensuring performance of project teams to deliver strategic and tactical outcomes. Interacts with a broad range of internal and external contacts to collect, analyze and recommend solutions to complex operational, compliance and regulatory challenges.

Optional hybrid work model.

How you will contribute:

This role is accountable for leading a team with the following responsibilities:

• Empowered quality representative for Global Product Teams, translating the global commercial strategy into operational strategy, for execution by the relevant Business Units. Accountable for consulting and informing all relevant quality stakeholders to ensure aligned, strategic decision making.

• Provide quality expertise in accordance with global regulatory requirements and internal policies in the creation of Product Characterization, Product Specifications, Method Validation, Stability and Comparability assessments for tech transfers

• Support quality review of regulatory submissions (i.e. filings, annual reports, responses to questions, progress reports for regulatory commitments), ensuring submissions are in line with the operational strategy, GMP requirements and are verified for accuracy and data integrity.

• Represent Product Quality program in CMC meetings with global regulatory agencies and during regulatory inspections

• Represent Quality in Global CMC and Commercialization teams

• Quality lead supporting business growth in product launch, due diligence, divestment and integration activities and works in partnership with relevant stakeholders to influence quality strategy.

• Lead product quality related cross-functional teams – Quality Matrix Team (QMT)

• Maintain oversight of product performance and develop countermeasures via strategic and tactical quality input to develop sustainable compliant product with continuity of supply.

• Supports the Incident Escalation process.

• Support the definition of product critical quality attributes, deliver and drive control strategy, deliver phase-appropriate product specifications.

• Provide quality oversight and guidance during product launch, key member of the Global product launch team

• Provide strategic guidance in support of the timely implementation of multi-site global changes with regulatory impact

• Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase

• Provides Quality input to establish preferred Supply Chain architecture. In collaboration with relevant stakeholder’s, develops recommendations which improve product, process and supply chain architecture strategies and establishes key product launch considerations, attributes and profiles for those products nearing commercialization

Technical/Functional (Line) Expertise

Subject Matter Expertise in assigned product platform (Biologics)

Leadership

Experience in managing teams at a site level desirable, experience in leading global teams advantageous. Clear communicator, ability to distil complex information into clear and concise key points and make recommendations regarding necessary course of action. Ability to listen and understand different functional needs and perspectives, and influence others. Positive and accountable change agent, with ability to formulate and execute vision and create a culture of continuous improvement. Ability to build strong collaborative working relationships with OpUs, sites and global functions.

Decision-making and Autonomy

Accountable and empowered quality representative for all strategic decisions endorsed by the Global Product Teams, impacting product quality, in consultation with key quality stakeholders. Based on the complexity and impact of decisions, will consult or inform relevant stakeholders.

Interaction

Interacts with senior Quality and GMS leadership, as well as primary liaison with regulatory agencies in terms of response to questions pertaining to CMC sections of regulatory submissions.

Innovation

Technical expertise to support the development and evolution of products during various lifecycle phases. Sharing knowledge with internal stakeholders to facilitate scientific and compliance based decision making.

Complexity

Ability to operate in an internal and external business envionrment globally, across many different cultural considerations and complex regulatory frameworks.

What you bring to Takeda:

• BSc. / BEng. or equivalent essential, MSc./Eng. preferred, business related post graduate education an advantage.

• Minimum 8 - 10 years experience across a range of quality, technical operations or regulatory functions, experience operating at global level essential

• Operational experience as a licensed QP desirable

• Leadership experience of managing globally located teams highly desirable

• Subject Matter Expertise in one product platform (Biologics, Plasma or Small Molecule)

• Ability to work autonomously, and an understanding of when to consult/inform/escalate

• Strong relationship building skills, and ability to work in partnership cross functionally with global stakeholders

• Business alignment acumen with ability to understand commercial strategy and financial literacy

What Takeda can offer you:

Full Healthcare Cover - includes dependents

Pension Scheme

Attractive Bonus

Subsidised canteen

Parking facilities with electric car charging points

Health & Wellness programs including onsite flu shots and health screenings

Educational Assistance

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

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, or any other characteristic protected by law.

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