Quality Council Executive Level lll

at  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 QA Executive Level III - Quality Council role is required to support activities within the scope of responsibilities the Quality Compliance Group at Viatris Galway. These responsibilities include regulatory compliance, inspection readiness for pharmaceutical and medical device products and Quality Management System (QMS) oversight ensuring it aligns with regulatory requirements and industry standards.
The position will support quality council activities, self-inspection and external auditing activities to ensure compliance of the Quality management system to Pharmaceutical and Medical Device regulations, standards, applicable guidance and global policies. The role will support in preparation for external health authority, notified body, customer and corporate audits and support with the coordination and compliance input into audit responses and their corrective/preventative action plans.

Every day, we rise to the challenge to make a difference and here’s how the QA Executive Level III (Quality Council) role will make an impact:

• Interface with site operation owners to collect and analyze key data related to Quality Metrics.
• Establish and provide consistent timely analysis and publication of key quality metrics with Global partners.
• Prepare and deliver presentations and detailed analysis results for Quality metrics to site Quality Council for timely delivery to global partners.
• Provide support with other team members in coordination, preparation and management of health authority, notified body, corporate or customer audits whether virtual or onsite.
• Provide support in coordination of the internal audit program with other team members.
• Support the coordination and implementation of the relevant impact assessments for the purpose of assessing new & Revised Standards e.g. relevant ISO standards and global policies when requested
• Schedule and assist in the execution of the Site Quality Council/ Management Review meetings.
• Provide support in ensuring the quality management system is compliant to EU MDR2017/745 for medical device products e.g. Post Market Surveillance activities.

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:

• Minimum of a Bachelor’s degree (or equivalent) and 0-2 years of experience working the in pharmaceutical/medical device industry.
• Good working knowledge of applicable standards and regulations for sterile manufacturing, with preference for EU GMP Chapter IV Annex 1, ICH 210, 211, 21 CFR 820, Part 4 & Part 11 Compliance, EU MDR2017/745, ISO13485:2016 and MDSAP.
• Must possess the ability to understand technical documents and can communicate description of problems and solutions.
• Excellent attention to detail.
• Strong interpersonal and organizational skills.
• Computer skills including Word, Excel and MS Outlook.
• Excellent communication (both oral & written), interpersonal and presentation skills

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 QA Executive Level III (Quality Council) role will make an impact:

• Interface with site operation owners to collect and analyze key data related to Quality Metrics.
• Establish and provide consistent timely analysis and publication of key quality metrics with Global partners.
• Prepare and deliver presentations and detailed analysis results for Quality metrics to site Quality Council for timely delivery to global partners.
• Provide support with other team members in coordination, preparation and management of health authority, notified body, corporate or customer audits whether virtual or onsite.
• Provide support in coordination of the internal audit program with other team members.
• Support the coordination and implementation of the relevant impact assessments for the purpose of assessing new & Revised Standards e.g. relevant ISO standards and global policies when requested
• Schedule and assist in the execution of the Site Quality Council/ Management Review meetings.
• Provide support in ensuring the quality management system is compliant to EU MDR2017/745 for medical device products e.g. Post Market Surveillance activities

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

• Minimum of a Bachelor’s degree (or equivalent) and 0-2 years of experience working the in pharmaceutical/medical device industry.
• Good working knowledge of applicable standards and regulations for sterile manufacturing, with preference for EU GMP Chapter IV Annex 1, ICH 210, 211, 21 CFR 820, Part 4 & Part 11 Compliance, EU MDR2017/745, ISO13485:2016 and MDSAP.
• Must possess the ability to understand technical documents and can communicate description of problems and solutions.
• Excellent attention to detail.
• Strong interpersonal and organizational skills.
• Computer skills including Word, Excel and MS Outlook.
• Excellent communication (both oral & written), interpersonal and presentation skill