Viatris

Mylan Teoranta

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 senior will support activities to ensure compliance of the Quality Management System to Pharmaceutical and Medical Device regulations, standards, applicable guidances and global policies. They are responsible for ensuring a compliant quality assurance program is in place for new product introduction, risk management, and ensuring audit readiness. The role will support in the review of site quality metrics and communication and will act as designee to the sight quality council lead when necessary.

The role is responsible for supporting risk management per the guidance ISO 14971:2019, and compliance of the quality system with ISO 13485:2016 Medical Device Directive (MDD) 93/42/EEC, EU MDR 2017/745 and applicable Medical Device Coordination Group (MDCG) guidance, and Medical Device Single Audit Program (MDSAP). The role may become the Identified Person Responsible Regulatory Compliance if experience and education meet the requirements of EU MDR.

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

• Role responsibilities
• Coordination and reporting of post market surveillance activities and Post Market Clinical follow-up per EU MDR requirements for medical device products
• Support the review update or generation of uFMEA, dFMEA and pFMEA documentation within the risk management file for medical device products
• Support new product introduction to the site and new product launches as required ensuring adherence to QMS processes
• Stay abreast of changing requirements/expectations and proactively address within the quality system.
• Responsible for the coordination and implementation of the relevant impact assessments for the purpose of assessing New & Revised Standards and global policies
• Assist in the preparation and management of health authority, notified body, corporate or customer audits at site.
• Act as designee for Compliance Manager- Program Management when required.
• Perform other actions as assigned to adapt to changing needs in business

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:

• Role requirements
• Good working knowledge of applicable standards and regulations for sterile manufacturing, with preference for EU GMP Chaper IV Annex 1, ICH 210, 211, 21 CFR 820, Part 4 & Part 11 Compliance, EU MDR2017/745, ISO13485:2016 and MDSAP
• Experience with Risk Assessment tools such as FMEA, Fault Tree analysis, 5 Whys, HACCP is preferable
• Excellent communication (both oral & written), interpersonal and presentation skills
• Candidates should be self-motivated with the ability to work on their own initiative and should possess excellent organizational and time management skills with the ability to handle multiple tasks in a fast-paced environment.
• Minimum of a Bachelor's degree (or equivalent) in a science or engineering related discipline and a minimum of 5 years relevant experience within a sterile manufacturing facility at management level or an MSc / MEng degree (or equivalent ) in a related discipline and a experience within a sterile pharmaceutical manufacturing facility and / or Medical Device, Combination Product manufacturing is preferable

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.