- Ensure that site Quality Systems are in alignment with EU directives, relevant health authority submissions, cGMPs as well as company policies and procedures.
- Provide strategic and compliance-related technical input to the site initiatives and changes associated to enterprise systems.
- Direct and oversee the preparation of APRs/PQRs adhering to the timelines established.
- Oversee the change control system, and ensure the appropriate compliance management and coordination of change controls associated to electronic/computerised systems, facilities, utilities, etc.
- Lead the site's different representatives and departments when managing audits from regulatory health agencies or Global Quality.
- Manage market complaints and PMSIs.
- Direct strategic development, planning and execution of goals in alignment with global objectives.
- Manage supplier non-compliance notifications, vendor qualification, quality technical agreements and excipients risks assessments.
- Determine group structure, ensure the development of talent for effective succession and carry out performance assessments.
- Ensure the efficient performance of the Quality groups assigned to the role and GMP required systems through the continuous review of resources and systems' throughput and implementation of new tools, technology and business processes.
- Coordinate the forecasting process for required business statistics/information and reporting as well as the operational/expense budget and capital budget.
- Review monthly budget performance and control staffing/headcount across the Quality groups.
- Manage and maintain robust relationships with the Viatris internal leadership team, industry colleagues and with the HPRA & FDA organisations.
- Bachelor's degree in a relevant field, such as Pharmacy, Chemistry, Biology or a related discipline.
- 5-7 years of extensive experience in quality management systems, regulatory compliance, or a related area within the pharmaceutical industry, with a focus on compliance with GMP and regulatory requirements.
- Experience in managing compliance programmes, ensuring adherence to regulatory standards and implementing quality systems.
- In-depth knowledge of relevant regulations and guidelines, such as EMA, ICH and other global regulatory requirements.
- Leadership and people management skills.
- Excellent career progression opportunities
- Work-life balance initiatives
- Bonus scheme
- Health insurance
- Pension
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Senior Quality Compliance Manager - County Dublin, Ireland - Viatris
Description
Rottapharm 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 Senior Quality Compliance Manager role will make an impact:
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:
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:
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
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
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.
