Director – Data Management and Governance for RDQ

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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.

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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

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

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt 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.