Senior Manager, Quality Operations Systems

at  Viatris

Upjohn Manufacturing Ireland Unlimited
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
The Quality Operations (QO) Systems Senior Manager leads and manages the QO Systems team. The team has responsibility for the implementation of new QC systems and maintaining the existing laboratory systems at Viatris Little Island.
The role incorporates responsibility in the areas of laboratory systems and applications; implementation, compliance, LIMs template builds, budgeting, and resourcing. The QO Systems Senior Manager will proactively manage the team to ensure laboratory systems are maintained
according to Viatris cGMP standards and seeks opportunities for improvement.

Every day, we rise to the challenge to make a difference and here’s how the Senior Manager, Quality Operations Systems role will make an impact:

• Ensure the multiple QC IT systems are adequately validated, maintained and compliant with GMP requirements, incl. FTIR, X-ray, LCMS, AA, LabX Karl Fischer, Malvern, UV, Coulter Counter, DSC.
• Install and validate lab instrumentation and IT Systems as required and in line with site safety and quality requirements.
• Support Global QC laboratory systems LIMS and interfaces requirements, Empower, Netbackup and NuGenesis, Acronis site requirements.
• Ensure LIMS builds are completed as required to meet Production schedule.
• Ensure Empower remains in a compliant state with responsibility for Empower project deliverables as required.
• Ensure all equipment is calibrated in accordance with the calibration schedule.
• Ensure maximum up-time for all systems and breakdowns/repairs are resolved as soon as possible.
• Provide Operational Administrator Access support/troubleshooting for all QC equipment and IT Systems to ensure batch release (Supply) is maintained in line with value stream and customer requirements.
• Manage the vendor services from induction and permitting through to service reporting.
• Ensure the systems meet all Data Integrity requirements for ERES, Audit Trail Assessments and ALCOA+.
• SME for Data Integrity and support cross site DI forums as required.
• Support VIOS (Viatris Integrated Operating System) deployment in QC in accordance with site strategy.
• Ensure the team deliver on site metrics – Training, Trackwise and SIMS with other site metrics as relevant.
• Participate in CI projects with the focus on projects that will deliver the highest benefit for all system users, the QC Laboratory and Production timelines.
• Strategic direction for QC IT systems and system infrastructure – planning for the future.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Bachelor of Science Degree in chemistry, engineering, or another related discipline.
• 5+ years of experience in a cGMP laboratory environment.
• People management experience or genuine interest in managing a team.
• Demonstrated thorough knowledge of all aspects of laboratory IT systems and applications.
• In-depth technical knowledge of LIMS (LIMS master data) and Empower.
• Experience with building master data and templates.
• Demonstrated ability to achieve results.
• Demonstrated ability to cope with complexity and changing environments.
• Ability to extract data from QO systems and generate reports.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit
https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit
https://www.viatris.com/en/about-us/corporate-responsibility
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.

Every day, we rise to the challenge to make a difference and here’s how the Senior Manager, Quality Operations Systems role will make an impact:

• Ensure the multiple QC IT systems are adequately validated, maintained and compliant with GMP requirements, incl. FTIR, X-ray, LCMS, AA, LabX Karl Fischer, Malvern, UV, Coulter Counter, DSC.
• Install and validate lab instrumentation and IT Systems as required and in line with site safety and quality requirements.
• Support Global QC laboratory systems LIMS and interfaces requirements, Empower, Netbackup and NuGenesis, Acronis site requirements.
• Ensure LIMS builds are completed as required to meet Production schedule.
• Ensure Empower remains in a compliant state with responsibility for Empower project deliverables as required.
• Ensure all equipment is calibrated in accordance with the calibration schedule.
• Ensure maximum up-time for all systems and breakdowns/repairs are resolved as soon as possible.
• Provide Operational Administrator Access support/troubleshooting for all QC equipment and IT Systems to ensure batch release (Supply) is maintained in line with value stream and customer requirements.
• Manage the vendor services from induction and permitting through to service reporting.
• Ensure the systems meet all Data Integrity requirements for ERES, Audit Trail Assessments and ALCOA+.
• SME for Data Integrity and support cross site DI forums as required.
• Support VIOS (Viatris Integrated Operating System) deployment in QC in accordance with site strategy.
• Ensure the team deliver on site metrics – Training, Trackwise and SIMS with other site metrics as relevant.
• Participate in CI projects with the focus on projects that will deliver the highest benefit for all system users, the QC Laboratory and Production timelines.
• Strategic direction for QC IT systems and system infrastructure – planning for the future

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Bachelor of Science Degree in chemistry, engineering, or another related discipline.
• 5+ years of experience in a cGMP laboratory environment.
• People management experience or genuine interest in managing a team.
• Demonstrated thorough knowledge of all aspects of laboratory IT systems and applications.
• In-depth technical knowledge of LIMS (LIMS master data) and Empower.
• Experience with building master data and templates.
• Demonstrated ability to achieve results.
• Demonstrated ability to cope with complexity and changing environments.
• Ability to extract data from QO systems and generate reports