At a Glance
- Tasks: Lead validation activities for lab and manufacturing systems, ensuring compliance and data integrity.
- Company: Viatris, a global leader in healthcare committed to making a difference.
- Benefits: Competitive salary, inclusive culture, career progression, and work-life balance.
- Other info: Diverse and inclusive workplace with opportunities for personal and professional growth.
- Why this job: Join a purpose-driven team and impact global health through innovative IT solutions.
- Qualifications: Bachelor’s degree in relevant field and extensive IT experience in pharma or biotech.
The predicted salary is between 36000 - 60000 € per year.
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.
Manager QA IT - Based Anywhere in Europe in Hatfield employer: Viatris
At Viatris, we are dedicated to transforming healthcare and empowering our employees to make a meaningful impact. Our collaborative culture fosters personal growth and resilience, offering competitive salaries, comprehensive benefits, and a commitment to diversity and inclusion. With opportunities for career progression and a focus on work-life balance, Viatris is an exceptional employer for those looking to contribute to healthier communities across Europe.
StudySmarter Expert Advice🤫
We think this is how you could land Manager QA IT - Based Anywhere in Europe in Hatfield
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those at Viatris. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by diving deep into Viatris' mission and values. Show us how your experience aligns with our commitment to healthcare and making a difference. We love candidates who resonate with our purpose!
✨Tip Number 3
Practice your STAR technique for answering behavioural questions. We want to hear about your past experiences and how they’ve shaped you into the perfect fit for the Manager QA IT role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows us you’re genuinely interested in being part of the Viatris family.
We think you need these skills to ace Manager QA IT - Based Anywhere in Europe in Hatfield
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Manager QA IT. Highlight your experience with Computer System Validation and any relevant IT oversight you've done in the pharmaceutical or biotech industry. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background makes you a great fit. Don’t forget to mention your understanding of regulations like 21 CFR Part 11 and EU Annex 11, as these are key to the position.
Showcase Your Problem-Solving Skills:In your application, be sure to highlight specific examples where you've tackled challenges in IT or compliance. We love candidates who can demonstrate their problem-solving abilities, especially in relation to risk assessments and data integrity.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us that you’re serious about joining our team at Viatris!
How to prepare for a job interview at Viatris
✨Know Your Regulations
Make sure you brush up on the key regulations like 21 CFR Part 11 and EU Annex 11. Being able to discuss how these apply to IT systems will show that you understand the compliance landscape and can navigate it effectively.
✨Showcase Your Technical Skills
Be prepared to talk about your experience with Computer System Validation (CSV) and specific systems like LIMS, CDS, or MES. Bring examples of how you've successfully implemented or managed these systems in past roles to demonstrate your expertise.
✨Emphasise Collaboration
Since this role involves liaising between various teams, highlight your teamwork skills. Share examples of how you've worked with QA, IT, and lab staff to achieve common goals, showcasing your ability to foster collaboration.
✨Prepare for Problem-Solving Questions
Expect questions that assess your problem-solving abilities, especially in risk assessment and documentation. Think of scenarios where you identified a problem, assessed risks, and implemented solutions, and be ready to discuss them in detail.
