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Job Description

Job Title: Head, R&D Quality - Digital Capability and Delivery

Location: Cambridge, MA

About the role:

• Provide leadership and framework to R&D teams to improve digital capability.
• Oversee delivery of digital project pipeline for Data Analytics and Innovation team with integrated stage-gate governance at each project phase
• Stewards the development of R&D Quality Strategic Digital Roadmap according to partner priorities.

How you will contribute:

• Can navigate and work within complex organizations and across departments, including at senior levels.
• Collaborate with peers and partners, and build sustainable relationships.
• Experience working cross-functionally and in matrixed, global teams.
• Communicate across departments and unite people around common goals and priorities with a keen focus on customer service.
• Lead conflict resolution
• Affirm grasp of industry, scientific and regulatory trends, expert-level understanding of market conditions and ability to identify and use innovation to evolve Takeda to become an industry leader
• Guide new ways of thinking and lead change.
• Identify and lead transformational projects of major magnitude and global scope.
• Develop and implement solutions to complex issues which potentially affect the R&D Quality Management System, and ensure full compliance with applicable cGxP regulations and Takeda quality expectations.
• Lead and work independently in a complex, fast-paced environment.
• Analyze complex data/situations and make decisions promptly, often with limited information, and using the required all partners.
• Creative problem-solving skills and receiving support from all partners.

Minimum Requirements/Qualifications:

• Bachelor's required in Computer Science, life sciences or engineering
• 8 or more years of increasing responsibility and experience in the global pharmaceutical industry or healthcare
• Experience working in Agile teams or project management office
• Wide breadth and depth of experience in digital technologies
• Basic financial knowledge to access and oversee business case development
• Create a "Fit for Purpose" strategic roadmap for implementing digital technologies across R&D Quality partners (DSI, GMS/GQ, DD&T and R&D) to create value by mitigating study and product risks, maximizing efficiency and increasing compliance with quality standards.
• Provide strategic direction and guidance to improve capabilities of metrics programs, including collation, analysis and trending of data for R&D Quality Metrics.
• Improve use of digital capabilities across the organization by scouting technology (internal and external to Takeda) and managing its deployment within R&D Quality as an enabler for Quality risk mitigation, using enterprise platforms and tools in decision-making and rapid issue resolution.
• Create framework, governance, and leadership to digital project pipeline for R&D Quality by managing timelines, unblocking issues, and coaching team members on Agile methodologies to ensure smooth progression of projects.
• End-to-end creation, development, and oversight of Portfolio processes. including delivery plans, portfolio tracking and reporting, project methodology framework, communication and resource capacity management.
• Develop project proposals by facilitating brainstorming or problem-solving workshops to understand our challenges related to audit management, Supplier management, QMS workflows and co-create solutions with Quality Compliance and Systems, Clinical QA, Research QA, Pharmacovigilance & Medical Quality, Pharmaceutical Sciences and Device Quality and Cell Therapy Quality teams.
• Oversight and execution of the Data Analytics and New Innovation plan across the digital project portfolio. Develop benchmarking metrics and measures of success for assessing successful execution of the operating model.
• Lead project teams in best practices in digital/data and project management.
• Solid experience in digital transformation, data integration, data modeling, modern database query languages, and AWS cloud technologies
• Experience with Agile Software Development methodologies including building Kanban/scrum boards for tracking updates
• Perform diagnosis and root cause analysis and identify opportunities for improvement
• Build processes that support data transformation, workload management, data structures, dependency and metadata
• Knowledgeable of healthcare and trends in digital technologies
• Understanding of data integrity and data lifecycle concepts to support appropriate use of data
• Experience with pharmaceutical research and development, manufacturing, and related technologies.

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 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.

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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.

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