Takeda Pharmaceutical Hiring for Product Quality Lead (Associate Director) Job at Boston, MA Full Time

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Job Description

Job Title: Product Quality Lead (Associate Director)

s to: Director, Product Quality & Analytical Services

Location: Cambridge, MA (Hybrid), ZURICH or IRELAND

About the role:

The Product Quality Lead (PQL), Small Molecule and Oncology, will provide global quality oversight of Takedas’ products, across the assigned product technology platform, from the late clinical development phase through commercialization and throughout the lifecycle. You will be part of a team of Product Quality Leads and be involved in the development of the strategy to 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 with GMP operations to support assigned programs.

You will ensure there is a thoughtful level of communication, related to the quality aspects across the Global Product Teams, manufacturing sites, and global departments. They are the designated accountable representative for Quality decision-making at a strategic level, and with partners.

• Primary responsibility for the strategic quality oversight of our global commercial Oncology and External Supply Small Molecule product portfolio.

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

• Help develop product strategies based on our businesses’ needs and product lifecycle for both commercial products and products at late-stage development.

• Support long-term quality goals for the global product portfolio, and for supporting ongoing continuous improvement.

How you will contribute:

You will lead a team with the following responsibilities:

• An empowered quality representative for Global Product Teams, translating the global commercial strategy into an operational strategy, for execution by the relevant departments. Consult and inform all relevant quality partners to ensure aligned strategic decision-making.

• Provide quality expertise following 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 s, responses to questions, progress s for regulatory commitments), ensuring submissions are following 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

• The Quality Lead supports business growth in product launch, due diligence, divestment, and integration activities and works in partnership with relevant partners to influence quality strategy.

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

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

• Support the Incident Escalation process.

• Help define product important quality attributes, deliver control strategy, and deliver phase-appropriate product specifications.

• Provide quality guidance during a product launch, an important member of the Global product launch team

• Provide strategic guidance to help implement multi-site global changes with regulatory impact

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

• Provide Quality input to establish preferred Supply Chain architecture. In collaboration with relevant partners, develops recommendations that improve product, process, and supply chain architecture strategies and establishes important product launch considerations, attributes, and profiles for those products nearing commercialization

• 
  Technical/Functional (Line) Expertise: Subject Matter Expertise in assigned product platform (Oncology/Small Molecule)

• 
  Leadership: Experience managing teams at a site level is desirable, and experience leading global teams is advantageous. The ability to distill complex information into concise important points and make recommendations regarding a necessary course of action. Understand different functional needs and perspectives. To be an accountable change agent, with the vision to create a culture of continuous improvement. Build collaborative, working relationships with OpUs, sites, and global departments.

• 
  Decision-making and Autonomy: Accountable and empowered quality representative for all strategic decisions endorsed by the Global Product Teams, improving product quality, with important quality partners. Based on the complexity and the effect of decisions, you will consult or inform relevant partners.

• 
  Interaction: Work with senior Quality and GMS leadership, and a primary liaison with regulatory agencies regarding responses to questions about CMC sections of regulatory submissions.

• 
  Innovation: Technical expertise to support the development and evolution of products during several lifecycle phases. Sharing knowledge with team members to facilitate scientific and compliance-based decision-making.

• 
  Complexity: Operate in an internal and external business environment globally, across many different cultural considerations and complex regulatory frameworks.

What you bring to Takeda:

Essential Skills and Education:

• BSc. / BEng

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

• Subject Matter Expertise in the small molecules product platform

• The ability to work with global partners

• Business knowledge and understanding of commercial strategy and financial literacy

Desired Skills and Education:

• MSc./Eng., business-related post-graduate education an advantage.

• Operational experience as a licensed Quality Professional (QP)

• Leadership experience managing globally located teams is desirable

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 a company match of charitable contributions

• Family Planning Support

• Professional training, and professional 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.

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 to inspire and empowers 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.

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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

Boston, MA

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time