Operations Director Medical Devices jobs

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.

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 Director role will make an impact:

You will lead the MDR Quality Operations team (Quality Compliance, QA, QC), ensuring compliance with training, SOPs, EU and US FDA requirements, and GMP. You will apply Global Quality Standards across the site and external network to maintain strong GxP compliance and continuous improvement. The role provides quality oversight across supply, manufacturing, inhaler assembly, packaging, testing, and release, while driving a strong Culture of Quality to deliver high-quality products every day, every dose, for every patient.

• Continue to develop, implement, improve and maintain the Quality Management System and Compliance Strategy that reflects the regulatory expectations, business model and objectives for the site.

• Ensure timely, efficient and effective communication of Quality issues with Snr. Management and external organisations as necessary.

• Ensure that all manufacturing, packaging, testing and release activities are carried out in accordance with written procedure and as stipulated in relevant submissions/authorizations.

• Provide leadership and support to the Quality operations team to ensure that the site is audit ready and that any deviations from procedures/instructions and/or abnormal events are investigated and documented and suitable corrective/preventative actions are taken.

• Recruit, train and develop personnel to adequately resource all Quality operations activities including adequate provision of the QP release function in line with EU directives far the certification of drug product.

• Lead and play key role in all interactions with HPRA, FDA and other health authorities as required.

• Develop and manage metrics to ensure performance and continued review and improvement of the Quality Management System, QC testing function and Product Release.

• Review and critique documents intended for regulatory submission. Review systems and procedures, add, modify, and streamline as appropriate.

• Ensure that the vendor management program ls efficiently and effectively managed.

• Coordinate the development and monitor performance of the budget and headcount strategy for the site Quality Unit.

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:

• Experience of leading Audits and direct interaction with Health Authorities is essential.

• Work experience as a QP with direct experience releasing batches to market.

• Third Party release and quality oversight experience is desirable

• Experience with Lean manufacturing/labs

• Strong leadership/team management skills and experience.

• Experience with Medical Device Regulations and combination products is preferred.

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.