Manager Quality Assurance IT

McDermott Laboratories Limited

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

Every day, we rise to the challenge to make a difference and here’s how the Manager QA IT role will make an impact:

• Computer System Validation (CSV) & IT Oversight - lead and support validation activities for laboratory and manufacturing systems (LIMS, CDS, MES, EBR, QMS, etc.).  Ensure systems comply with 21 CFR Part 11, Annex 11, and other applicable data integrity requirements.  Review and approve user requirements, validation documentation, and change controls related to computerized systems.

• Quality & Compliance - ensure data integrity across all computerized systems in compliance with ALCOA+ principles.  Develop and review protocols, and policies related to electronic systems and IT quality processes.

• Collaboration & Support - act as liaison between QA, IT, laboratory staff, and manufacturing operations.  Train users on data integrity, electronic records, and compliance with IT-related systems.  Support electronic quality management systems (QMS) for deviations, and change management.

• Risk & Security - conduct IT-related risk assessments for laboratory and manufacturing systems.  Oversee access controls, audit trails, and cybersecurity considerations for regulated systems.  Support disaster recovery planning and data backup/restore processes in alignment with compliance requirements.

• Change control, SOP/Guideline management, Risk Analysis, CSV lifecycle based on ISPE GAMP5 guidance, and Periodic Reviews

• Perform other duties as assigned.

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’s degree in Life Sciences, Computer Science, Information Technology, or related field. Extensive years of experience in IT within a pharmaceutical, biotech, or medical device industry.

• Knowledge of FDA, EMA, and ICH regulations, including 21 CFR Part 11 and EU Annex 11.Experience with Computer System Validation (CSV).

• Understanding of laboratory and manufacturing computerized systems (LIMS, CDS, MES, EBR, TrackWise, Master Control, etc.).

• Ability to interpret regulatory requirements and apply them to IT and digital systems.

• Problem-solving, risk assessment, and documentation skills.

• Familiarity with GAMP 5 guidelines for computerized systems.

• Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. 

• Ability to perform computations such as percentages, ratios, and rates. 

• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. 

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.

Why 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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

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 offercompetitivesalaries, benefitsandan 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.