Associate Quality Director - Qualified Person
Job Description
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities.
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 Associate Quality Director / QP has responsibility for administration of the Quality Management System at Mylan Teoranta (A Viatris Company), with responsibility to ensure products are manufactured according to all applicable regulatory and corporate guidelines. The Associate Quality Director II/ QP is responsible for the day to day management of the QA department, identified as the Management representative per the requirements of ISO 13485: 2016; reports directly to the Associate Quality Director II/ QP and where relevant is the nominated designate.
Every day, we rise to the challenge to make a difference and here’s how the X role will make an impact:
QP & Batch Release
Act as Lead QP, ensuring compliant release of all batches.
Oversee batch release processes and review batch documentation for accuracy and compliance.
Collaborate with production to resolve release issues and maintain timelines.
Quality Leadership
Lead and manage the Quality Assurance department, including mentoring QA Team Leads.
Own and approve the Quality Management System (QMS).
Drive a strong quality culture and continuous improvement mindset across the site.
Compliance & Audits
Ensure inspection readiness and lead regulatory inspections (e.g. FDA, HPRA).
Manage audits and responses with regulatory bodies, customers, and corporate teams.
Stay current with evolving regulatory requirements and implement necessary updates.
Quality Systems Oversight
Own key quality processes including:
Deviations / Non-Conformance (NC)
CAPA management
Change control & impact assessments
Support new product introduction (NPI) and product launches from a quality perspective.
Stakeholder & Operational Management
Provide technical quality guidance across the site.
Influence decision-making to ensure compliant, risk-based outcomes.
Manage resources, workload, and departmental budget.
Engage with senior stakeholders at a global level.
People Leadership
Develop, coach, and retain QA talent.
Drive performance management, capability development, and succession planning.
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:
· Strong experience in sterile pharmaceutical and/or medical device manufacturing.
· Deep expertise across quality systems (deviations, CAPA, audits, change control, supplier quality).
· In-depth knowledge of global regulatory requirements, including:
EU GMP (Annex 1 & Annex 16)
FDA / 21 CFR (210, 211, 820)
ICH guidelines and Part 11 compliance
· Proven experience working with health authorities and notified bodies.
· Strong people leadership and team management experience.
· Excellent communication and stakeholder engagement skills.
· Ability to work in a fast-paced, complex environment and manage multiple priorities.
· Analytical, solution-oriented mindset with continuous improvement (Lean / Six Sigma) awareness.
· High level of decision-making confidence and influence.
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.