Manager QA IT - Based Anywhere in Europe

Viatris; Hatfield; On-site; GBP 45,000 - 60,000; Full time

Job summary

A global healthcare company is seeking a skilled IT Compliance Specialist to lead validation activities for their laboratory and manufacturing systems in Hatfield, UK. This role requires extensive experience in the pharmaceutical or biotech industry, in-depth knowledge of FDA regulations, and strong problem-solving skills. You will ensure compliance with data integrity requirements and train users on electronic records. The company offers competitive salaries, benefits, and an inclusive work environment.

Benefits

Competitive salary

Career progression opportunities

Work-life balance initiatives

Qualifications

• Extensive experience in IT within the pharmaceutical or biotech industry.
• Understanding of laboratory computerized systems.
• Ability to interpret regulatory requirements.

Responsibilities

• Lead validation activities for laboratory and manufacturing systems.
• Ensure data integrity compliance across systems.
• Conduct IT-related risk assessments.

Skills

Knowledge of FDA regulations

Problem-solving skills

Data integrity compliance

Risk assessment

Education

Bachelor’s degree in Life Sciences or related field

Tools

LIMS

CDS

MES

Job description

Overview

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 through access, leadership and partnership. Our global portfolio includes brand-name products, generics, and offerings across 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 — it is a place to make a difference in the world.

The Role & What You Will Be Doing

• 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 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

• Bachelor’s degree in Life Sciences, Computer Science, Information Technology, or related field. Extensive 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 and write comprehensive reports and detailed business correspondence.
• Ability to perform computations such as percentages, ratios, and rates; ability to solve problems with semi-standardized solutions that require ingenuity.

Viatris is committed to building a diverse, inclusive and authentic workplace. If you’re excited about this role but your past experience doesn’t align with every requirement, we still encourage you to apply. You may be the right candidate for this or other roles.

Why 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 have opportunities for career progression and work-life balance initiatives.

Diversity & Inclusion at Viatris: Diversity and inclusion are essential to our mission. For more information, please visit the Viatris Careers Diversity and Inclusion page at the viatris.com site.

Sustainability at Viatris: Corporate social responsibility is fundamental to our mission. We work to advance responsible and sustainable operations and empower people to live healthier at every stage of life. To learn more about our efforts, please visit the Viatris corporate responsibility page at the viatris.com site.

Viatris is an Equal Opportunity Employer.