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Director, Data Management and Governance for RDQ

Employer
Takeda
Location
Lexington, Massachusetts
Start date
Feb 12, 2025
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Job Details

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Job Description

Job Title: Director, Data Management and Governance for RDQ

Location: Lexington, MA

About the role:

As a Director, Data Management and Governance for RDQ, you will maintain QMS data systems and data quality standards through data maintenance tasks and a high-level data governance strategy to ensure compliance with company and regulatory requirements. You will establish and maintain policies for end-to-end enterprise-wide data governance, ensuring data consistency, integrity, and security along with R&D and Global Quality partners. You will provide Quality expertise to enterprise-wide and R&D large-scale data projects to organize, collect, and standardize data to support business-critical needs. You will be reporting to the Head of Data & Digital R&D Quality.

How you will contribute:
  • Be the leader of the RDQ data program that includes integrated data flows with end-to-end data management control mechanisms, internalization of enterprise processes, enablement of automation, near-time data access/streaming data sets, efficient data query review, and flexibly allow inspiring technologies for insight derivation.

  • Be the primary Quality contact for R&D data governance council and related operations.

  • Lead the implementation and management of a data governance strategy with R&D, Global Quality and Enterprise partners, redefining raw data into applicable insights, helping us make informed decisions, optimize performance and achieve RDQ data strategy.

  • Advise, and work on data flow optimization including data capture, integration and use.

  • Subject Matter Expert for setting and maintaining GxP standards for future state with Takeda SDLC policies and QMS - including digital products and new technologies.

  • Support data principles, policies, and standards.

  • Develop data profiling and data quality methodologies and embed them into the processes involved in transforming data across the systems.

  • Manage and influence the data pipeline and analysis approaches, including data quality software to interrogate data sets.

  • Maintain documentation for business rules for data, and act as an expert on data definitions, data standards, data flows, legacy data structures, for R&D and stakeholders.

  • Perform root cause analysis on GxP issues on data anomalies and work with data stewards to resolve issues.

  • Define data governance operational processes following policies and standards, promoting roles and responsibilities.

  • Monitor compliance to standards and processes.

  • Support resolution of R&D governance issues and escalate.

  • Create, manage, and facilitate a Data Policy Governance process to identify and understand critical data issues and ensure data policy enforcement and compliance.

  • Ensure governance mechanisms are in place to manage access to data.

  • Conduct training sessions on the policy, standards, and processes.

  • Support leadership with communication of main governance priorities and successes across the enterprise.

What you bring to Takeda:
  • Bachelor’s degree required, Masters or Ph.D. preferred, in a quantitative discipline such as Statistics, Mathematics, Engineering, Computer Science, Econometrics or information sciences such as business analytics or informatics.

  • 8 to 10+ years of experience, including 3+ years of experience working in data engineering role in an enterprise environment Experience with pharma processes and familiarity with R&D data management practices.

  • Knowledge of data architecture (data lake, data visualization, hubs etc.) and modeling is required.

  • Experience with SDLC and processes for development of pharma R&D platforms; experience with validation/quality compliance requirements.

  • Experience of SQL for complex data querying and management

  • Experience developing solutions on cloud computing services and infrastructure in the data and analytics space.

  • Prior experience with GxP data products.

  • in-depth knowledge of product management in pharmaceutical industry (>5 years experience).

  • Experience in building, designing, or supporting scalable analytical data models (>5 years experience).

  • Experience in multiple database systems ensuring performance and data integrity.

  • Proficient in using Data Quality Platforms and Tech to enhance data accuracy.

  • Experience with Data Profiling and Discovery to identify hidden data patterns.

  • Interpret complex data, providing clear and applicable insights.

  • Implement Data Governance Practices to ensure data consistency and security.

  • Ensure compliance with Data Protection regulations and best practices.

  • Develop and maintain Data Quality Management Practices to uphold data standards.

  • Develop and implement solutions to complex issues which potentially influence the R&D Quality Management System, and ensure full compliance with applicable GxP regulations and Takeda quality expectations.

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:

  • May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

  • 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.

#GMSGQ

#ZR1

#LI-MA1

#LI-Hybrid

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:

$169,400.00 - $266,200.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

LocationsLexington, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Company

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, our organization spans the globe—colleagues across business units and functions face challenges head-on to deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.

As a values-based, R&D-driven biopharmaceutical leader headquartered in Japan, we focus our R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. In addition to our R&D efforts, we’re laser-focused on harnessing the power of data, digital, and technology to improve health outcomes for patients across the globe.

 

Since our founding in Japan, integrity and putting patients first have been at the heart of our identity. We're proud of our employees and their commitment to improving the quality of life for patients, and to working with our partners in health care in approximately 80 countries and regions. With each new breakthrough comes opportunities to develop your career, hone new skills, and create a brighter future

For more information, visit https://jobs.takeda.com/

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
United States

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