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Global Lab Systems Business Process Owner

Multiple Locations
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At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

Job ID R0125849 Date posted 06/18/2024 Location Multiple Locations

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Job Description

Job Title: Global Lab Systems Business Process Owner

Location: Lexington, MA

About the role:

You will drive the design and deployment of the QMS Enterprise GxP electronic system according to the Takeda QMS requirements, as well as be the global process expert for the Global Lab Systems including Labware LIMs and CDS applications to support the whole Takeda network including: Installation, System Configuration, Master Data Builds, Validation and documentation support, training other members on configuration and Master data management of the system, troubleshooting Labware related tickets and issues, and process improvement projects.

You will also maintain master data at global level and provide guidance for master data set-up for all methods, areas, partner with GMSGQ DD&T partners to guide and sustain the application portfolio and roadmap, and resolve issues related to the system. Secure and mobilize business resources necessary for implementation and maintenance of business process and associated core QMS applications (requirements management, end user testing, training and business procedures)

This is a hybrid role that will report to the Head of QMS.

How you will contribute:

  • Support the integration and implementation of new Quality related IT technologies within lab systems, following SDLC requirements.
  • Be an interface between local and global Quality related IT projects for lab systems (e.g. Global SME to Local Admin/SME)
  • Provide business operations support with other QC applications, LabX, MES, ERP.
  • Global Labware LIMS Data Owner including business case governance in Enterprise Data Backbone aka "data lake".
  • Support deployment plans of applicable lab systems. Align roadmap and strategy with global leadership, global system owners, global process owners and site leadership team.
  • Evaluate change controls on impact of supported systems, master data or affected reporting tools.
  • Maintain master data of supported systems in accordance with other existing IT Systems or procedures, including accurate documentation
  • Manage, and improve Lab System master data standards. Support the business and local teams in defining, approving and validating of new requirements. Support validations (e.g. review and approve).
  • Own, write and improve global procedures, processes, training material and guidelines. Give technical input to customer related procedures.
  • Provide troubleshooting support for global level issues that arise with the system. Global deviation and change control owner for responsible systems and workstreams.
  • Train and educate Takeda employees and contractors on access, use and administration of global Labware and other applicable lab systems.

What you bring to Takeda:

  • Bachelor´s degree in a relevant scientific or technical field.
  • 8+ years of experience and responsibility combined with technical operations background. Experience must include successful examples of managing change by influence without direct resource control.
  • Quality Control or Microbiology background required. Experience with end-to-end process for the QC and Microbiology from preparation, sampling, analysis to CoA creation.
  • Experience with Pharmaceutical Industry including cGMP relevant regulations (FDA, EMA, SFDA, etc),
  • Knowledge of 21 CFR Part 11, Annex 11 and related regulations associated with electronic records.

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.
  • Travel 20-30%

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:

$149,100.00 - $234,300.00

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.

Locations

Lexington, MA

Boston, MA, Vienna, Austria, Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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