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Product Quality Lead, Oncology and External Supply Small Molecule

Company: Takeda Pharmaceutical
Location: Salem
Posted on: August 7, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job Title: Product Quality Lead, Oncology, and External Supply Small Molecule

Location: Dublin, Ireland, Boston, MA, or Zurich, Switzerland

About the role:

The PQL - Small Molecule and Oncology, will provide global quality oversight of Takeda s products, across the assigned product technology platform, from the late clinical development phase through commercialization and throughout the lifecycle. They will be part of a team of Product Quality Leads and be involved in the development of the 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 Oncology and External Supply Small Molecule 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 quality objectives for the global product portfolio, and for supporting ongoing continuous improvement.

How you will contribute:

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

  • An 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, and 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 who supports 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 a 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, and deliver phase-appropriate product specifications.
  • Provide quality oversight and guidance during a product launch as a 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 stakeholders, develops recommendations that improve the product, process, and supply chain architecture strategies and establish key product launch considerations, attributes, and profiles for those products nearing commercialization and supply chain architecture strategies and establishes key product launch considerations, attributes and profiles for those products nearing commercialization
    What you bring to Takeda:
    • Educational requirements: A Bachelor s degree in Science or an Engineering discipline (A Master of Science or Engineering preferred)
    • Minimum 8 - 10 years experience across a range of quality, technical operations or regulatory functions, experience operating at a global level essential
    • Operational experience as a licensed QP is desirable
    • Leadership experience in managing globally located teams is 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 an ability to understand the commercial strategy and financial literacy
      What Takeda can offer you:
      • Comprehensive Healthcare: Medical, Dental, and Vision
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
      • Health & Wellness programs including onsite flu shots and health screenings
      • Generous time off for vacation and the option to purchase additional vacation days
      • Community Outreach Programs and company match of charitable contributions
      • Family Planning Support
      • Professional training and development opportunities
      • Tuition reimbursement
        Important Considerations:

        At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

        Work in a controlled environment requiring special gowning, and wear protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas.

        Need to remove all make-up, jewelry, contact lenses, nail polish, and/or artificial fingernails while in the manufacturing environment.

        Work in a cold, wet environment.

        Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

        Work near and around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.

        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.

        This posting excludes Colorado applicants.

        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.


        Boston, MA

        Dublin-Baggot Street, Ireland, Zurich, Switzerland

        Worker Type


        Worker Sub-Type


        Time Type

        Full time

Keywords: Takeda Pharmaceutical, Salem , Product Quality Lead, Oncology and External Supply Small Molecule, Healthcare , Salem, Massachusetts

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