BioSpace, Inc.
Global Business System Owner MODA and CDS
BioSpace, Inc., Lexington, Massachusetts, United States, 02173
Job Details
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Job Title : Global Business System Owner MODA and CDS
Location : Lexington, MAAbout the role:
Design, deploy and continuously improve Global QC LIMS MODA, Global CDS (Chromatographic Data Systems including global PLA software) and Global QC LIMS Labware Environmental Monitoring workstream which includes product related microbiological and utility monitoring.Foster QC labs, Sample logistic, Manufacturing area, Sterility Assurance and COA creation collaboration and best practices exchange enterprise-wide in alignment with the Global QC LIMS roadmap, Global Microbiology roadmap, DD&T Lab System roadmap, Lab of the Future Roadmap, GQ Roadmap, and Takeda Quality CultureDrive a proactive continuous improvement (CI) and eAGILE culture in the QC Microbiological, Logistic, Manufacturing areas and Utility testing labs via Agile enhancement process in Jira.Innovation: drive integration of Laboratories, Logistic and Manufacturing areas with promising digital technologies such as Nymi in collaboration with the software vendor for future system release/build upgrades.How you will contribute:
Act as Global process expert for the MODA, CDS and Labware application (EM workstream) to support the whole Takeda network including, but not limited to: user account management, Installation, System Configuration, Master Data builds, Validation and documentation support, training other members on configuration and Master data management of the system, break-fix and troubleshooting for related tickets and issues, support and lead process improvement projects and initiatives.Maintain and improve master data at global level and provide guidance for master data set-up for existing and new methods, areas, etc including user training strategyAct as professional global business process expert and support any trouble shooting activities.Support Global LIMS improvement projects and global system enhancement governanceSupport of existing and future Quality related IT technologies and Business System Owner for workstreams related to Environmental Monitoring, Microbial Testing, Sterility Assurance and Utility testing, dashboarding, metrics/KPIs and statistical trending.Support of the integration of new Quality related IT technologiesAct as an interface between local and global Quality related IT projects (e.g. Global SME to Local Admin/SME)Provide business operations support with other QC applications, LabX, MES, etc.Ensure business resource availability for system maintenance, improvement and deploymentGlobal LIMS Data Owner including business case governance in Enterprise Data Backbone aka "data lake".Define and contribute to global system roadmaps and strategies of deployment for Takeda and ensure priorities for site must win goals in Fiscal Year. Align roadmap and strategy with global leadership, global system owners, global process owners and site leadership team.Collaborate with the eAGILE leadership network and Global Quality leaders to ensure continuous progress and compliance for laboratoriesMonitor timelines to assure progress consistent with global plans and targeted improvementsDrive utilization of digital tools that enhance lab performance such as SmartQC, NymiSupport and enable enterprise level KPIs relevant to lab operations and Lab transformation capabilities e.g. via EDB and interfacingInterpret and give context to data and information from external benchmarking, gemba walks commitments, and escalation issues converting them into action items for systemic improvements of our laboratory networkOwn, write and improve global procedures, processes, training material and guidelines. Give technical input to customer related procedures.Support audits and inspections to provide data and information on requestGlobal deviation owner for responsible systems and workstreams
What you bring to Takeda:
Education / experience
Scientific or engineering graduate (BSc, MSc, PhD), preferably in Chemistry or Engineering10 years managerial experience and responsibility is preferredStrong Pharmaceutical technical operations backgroundExperience in pharmaceutical QCExperience in manufacturing process, product release and sterility assuranceExperience with LIMS and IT SystemsExperience working in an international environment is preferred.Extensive global pharmaceutical industry knowledgeBasic understanding of cGMP, 21 CFR Part 11 and related regulations associated with Bio/Pharmaceutical product manufacturingSkills
Strong analytical skillsStrong soft skills: Communication, change management, influencing without formal authorityExcellent English skills, both written and spokenAdvanced communication, moderation and presentation skills for virtual or classroom workshops or meetings, mails, posts, newsletters, screens with a large audience based on a predefined stakeholder analysis and communication planIndependent work, organizational thinking, critical judgmentAbility to assess processes and workflows to determine opportunities for improvementBehaviors
Living our values (Patient, Trust, Reputation and Business) covered by the Global Code of Conduct is a basic expectation for all Takeda employees.Strategic enterprise thinking, finding innovative ways to serve patients building reputation and trustCreating the environment that inspires and enables people, maximizing their total involvement, capabilities growth and potentialFocus on the critical few priorities and provide superior resultsTeam-oriented, cooperative, communicative, conflict resolution skills, flexible, reliableAbility to travelTechnical/Functional (Line) Expertise
Deep knowledge of the MODA, CDS and relevant Labware application and EM workstream functionalitiesStrong soft skills: communication, change management, influencing without formal authorityStrong analytical skillsDeep knowledge of the end to end EM workstream process from planning, preparation, sampling, logistic, lab, CoA creation and process output/control (CoA, trending, sterility assurance)Leadership
A firm grasp of industry, scientific and regulatory trends and market conditions, to develop solutions to enhance compliance , quality of life for patients, trust, reputation and business resultsEngage others, with impactful communication and credibility, to motivate and influence them without formal authorityEstablish productive relationships and partner with relevant stakeholders across the organization to ensure common understanding of objectives and achieve shared goalsPromote change by leading by example continuous improvement in our enterprise QC labs to create value for patients, Takeda organization and our shareholdersFocus on methods and results, to assure site ownership of targets and plans for the short and the long term;Decision making for enterprise wide improvements for the application and actively seeking opportunities for developmentDecision-making and Autonomy
Roles and responsibilities for global Business System Owners are clearly defined as part of the Computer System Validation Lifecycle standards and procedures at Takeda.Partner and align with SBOs, QSIs, DD&T OpU Lead, DD&T Leads, enterprise QC labs leadership and GMSGQ key stakeholders to create the Global QC LIMS program roadmaps.Decisions may impact all OpUs and enterprise sites due scope of the Global QC LIMS program.Support future roadmap creation with OpUs and enterprise sites.Interaction
Full alignment with SBOF, eAGILE leadership, DD&T leaders and Global Quality leaders to align Global QC LIMS roadmap and business casesStrong partnership with QC Site Heads, Site Quality Heads, Site Heads, DD&T Leads and Quality Global functions to ensure continuity of strong support and sponsorship for the Global QC LIMS programInnovation
Ability to drive process optimizations, in line with internal expectations and external benchmarksKeep updated with trends in the Pharma and Biotech industry related to lean and innovation at labsEncourages new ideas and innovative approaches from sites and drive integration of Global QC LIMS with promising digital technologiesComplexity
Impact across the enterprise of Takeda manufacturing and QC lab end to end process. Global scopeImportant 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
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:
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, MAAUT - Vienna - Kärntner Ring, IRL - Dublin - Baggot Street, Zurich, Switzerland
Worker Type Employee
Worker Sub-Type Regular
Time Type Full time
Job ExemptYes
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Job Title : Global Business System Owner MODA and CDS
Location : Lexington, MAAbout the role:
Design, deploy and continuously improve Global QC LIMS MODA, Global CDS (Chromatographic Data Systems including global PLA software) and Global QC LIMS Labware Environmental Monitoring workstream which includes product related microbiological and utility monitoring.Foster QC labs, Sample logistic, Manufacturing area, Sterility Assurance and COA creation collaboration and best practices exchange enterprise-wide in alignment with the Global QC LIMS roadmap, Global Microbiology roadmap, DD&T Lab System roadmap, Lab of the Future Roadmap, GQ Roadmap, and Takeda Quality CultureDrive a proactive continuous improvement (CI) and eAGILE culture in the QC Microbiological, Logistic, Manufacturing areas and Utility testing labs via Agile enhancement process in Jira.Innovation: drive integration of Laboratories, Logistic and Manufacturing areas with promising digital technologies such as Nymi in collaboration with the software vendor for future system release/build upgrades.How you will contribute:
Act as Global process expert for the MODA, CDS and Labware application (EM workstream) to support the whole Takeda network including, but not limited to: user account management, Installation, System Configuration, Master Data builds, Validation and documentation support, training other members on configuration and Master data management of the system, break-fix and troubleshooting for related tickets and issues, support and lead process improvement projects and initiatives.Maintain and improve master data at global level and provide guidance for master data set-up for existing and new methods, areas, etc including user training strategyAct as professional global business process expert and support any trouble shooting activities.Support Global LIMS improvement projects and global system enhancement governanceSupport of existing and future Quality related IT technologies and Business System Owner for workstreams related to Environmental Monitoring, Microbial Testing, Sterility Assurance and Utility testing, dashboarding, metrics/KPIs and statistical trending.Support of the integration of new Quality related IT technologiesAct as an interface between local and global Quality related IT projects (e.g. Global SME to Local Admin/SME)Provide business operations support with other QC applications, LabX, MES, etc.Ensure business resource availability for system maintenance, improvement and deploymentGlobal LIMS Data Owner including business case governance in Enterprise Data Backbone aka "data lake".Define and contribute to global system roadmaps and strategies of deployment for Takeda and ensure priorities for site must win goals in Fiscal Year. Align roadmap and strategy with global leadership, global system owners, global process owners and site leadership team.Collaborate with the eAGILE leadership network and Global Quality leaders to ensure continuous progress and compliance for laboratoriesMonitor timelines to assure progress consistent with global plans and targeted improvementsDrive utilization of digital tools that enhance lab performance such as SmartQC, NymiSupport and enable enterprise level KPIs relevant to lab operations and Lab transformation capabilities e.g. via EDB and interfacingInterpret and give context to data and information from external benchmarking, gemba walks commitments, and escalation issues converting them into action items for systemic improvements of our laboratory networkOwn, write and improve global procedures, processes, training material and guidelines. Give technical input to customer related procedures.Support audits and inspections to provide data and information on requestGlobal deviation owner for responsible systems and workstreams
What you bring to Takeda:
Education / experience
Scientific or engineering graduate (BSc, MSc, PhD), preferably in Chemistry or Engineering10 years managerial experience and responsibility is preferredStrong Pharmaceutical technical operations backgroundExperience in pharmaceutical QCExperience in manufacturing process, product release and sterility assuranceExperience with LIMS and IT SystemsExperience working in an international environment is preferred.Extensive global pharmaceutical industry knowledgeBasic understanding of cGMP, 21 CFR Part 11 and related regulations associated with Bio/Pharmaceutical product manufacturingSkills
Strong analytical skillsStrong soft skills: Communication, change management, influencing without formal authorityExcellent English skills, both written and spokenAdvanced communication, moderation and presentation skills for virtual or classroom workshops or meetings, mails, posts, newsletters, screens with a large audience based on a predefined stakeholder analysis and communication planIndependent work, organizational thinking, critical judgmentAbility to assess processes and workflows to determine opportunities for improvementBehaviors
Living our values (Patient, Trust, Reputation and Business) covered by the Global Code of Conduct is a basic expectation for all Takeda employees.Strategic enterprise thinking, finding innovative ways to serve patients building reputation and trustCreating the environment that inspires and enables people, maximizing their total involvement, capabilities growth and potentialFocus on the critical few priorities and provide superior resultsTeam-oriented, cooperative, communicative, conflict resolution skills, flexible, reliableAbility to travelTechnical/Functional (Line) Expertise
Deep knowledge of the MODA, CDS and relevant Labware application and EM workstream functionalitiesStrong soft skills: communication, change management, influencing without formal authorityStrong analytical skillsDeep knowledge of the end to end EM workstream process from planning, preparation, sampling, logistic, lab, CoA creation and process output/control (CoA, trending, sterility assurance)Leadership
A firm grasp of industry, scientific and regulatory trends and market conditions, to develop solutions to enhance compliance , quality of life for patients, trust, reputation and business resultsEngage others, with impactful communication and credibility, to motivate and influence them without formal authorityEstablish productive relationships and partner with relevant stakeholders across the organization to ensure common understanding of objectives and achieve shared goalsPromote change by leading by example continuous improvement in our enterprise QC labs to create value for patients, Takeda organization and our shareholdersFocus on methods and results, to assure site ownership of targets and plans for the short and the long term;Decision making for enterprise wide improvements for the application and actively seeking opportunities for developmentDecision-making and Autonomy
Roles and responsibilities for global Business System Owners are clearly defined as part of the Computer System Validation Lifecycle standards and procedures at Takeda.Partner and align with SBOs, QSIs, DD&T OpU Lead, DD&T Leads, enterprise QC labs leadership and GMSGQ key stakeholders to create the Global QC LIMS program roadmaps.Decisions may impact all OpUs and enterprise sites due scope of the Global QC LIMS program.Support future roadmap creation with OpUs and enterprise sites.Interaction
Full alignment with SBOF, eAGILE leadership, DD&T leaders and Global Quality leaders to align Global QC LIMS roadmap and business casesStrong partnership with QC Site Heads, Site Quality Heads, Site Heads, DD&T Leads and Quality Global functions to ensure continuity of strong support and sponsorship for the Global QC LIMS programInnovation
Ability to drive process optimizations, in line with internal expectations and external benchmarksKeep updated with trends in the Pharma and Biotech industry related to lean and innovation at labsEncourages new ideas and innovative approaches from sites and drive integration of Global QC LIMS with promising digital technologiesComplexity
Impact across the enterprise of Takeda manufacturing and QC lab end to end process. Global scopeImportant 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
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:
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, MAAUT - Vienna - Kärntner Ring, IRL - Dublin - Baggot Street, Zurich, Switzerland
Worker Type Employee
Worker Sub-Type Regular
Time Type Full time
Job ExemptYes