Mylan Teoranta
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.
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
As Director of Quality Assurance, you will be responsible for managing Quality teams support operations and release, providing oversight of all quality assurance activities within a sterile manufacturing facility.This role ensures that all products meet internal and external standards, comply with cGMP regulations, and fulfill regulatory and customer requirements. meet the highest standards of safety, quality, and efficiency.
You will be responsible to lead and oversee two critical functions within the Quality Assurance (QA) organization: the Batch Release Team (manufacture and packaging), quality incoming inspection and the Investigations & Corrective and Preventive Actions (CAPA) Team. This role ensures all drug products are released in compliance with regulatory requirements and internal quality standards, while driving timely, effective investigations and robust CAPA execution to support continuous improvement and inspection readiness.
You will be responsible for building strong people leadership and development. The successful individual will be responsible for building and nurturing high-performing teams, fostering a culture of collaboration, accountability, and continuous improvement.
Every day, we rise to the challenge to make a difference and here’s how the Director of Quality Assurance/ QP role will make an impact:
Support and lead the Qualified Persons (QP), provide strategic and operational leadership to the Batch Release and Investigations/CAPA teams, aligning with corporate objectives and global regulatory standards (FDA, HPRA, DERKA, etc.).
Manage the teams activities and develop strong decision makers and mentor site, fostering a culture of accountability, collaboration, and quality excellence. Direct quality oversight of product release processes, change control, CAPA, deviation management, and risk assessments.
Oversee the implementation and maintenance of the Quality Management System (QMS), serve as a senior Quality Approver.
Lead inspections and audits by regulatory authorities and ensure audit readiness at all times. Support self-inspection programs, to proactively drive continuous improvement initiatives in QA systems and processes.
Ensure robust documentation control, including management of batch records, standard operating procedures (SOPs), and quality manuals
Collaborate cross-functionally with Manufacturing, Packaging, Quality Control, R&D, Regulatory Affairs, Supply Chain and Global verticals to ensure cohesive quality operations.
Monitor, analyze, and report quality metrics and key performance indicators (KPIs) to senior leadership, driving data-informed decision-making.
Lead, mentor, and develop the Quality Assurance (QA) team to support a high-performance and continuous improvement culture.
Act as Senior Director designee when required.
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:
QP certified, Bachelors of Science (Pharmacy, Chemistry, Microbiology or related field), Advanced degree (M.S., Ph.D., MBA) preferred.
Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
Aseptic manufacturing expertise, proven experience in contamination control strategies
Extensive experience in the pharmaceutical industry with a strong understanding of sterile drug manufacture and cGMP requirements
Demonstrated ability to manage multiple strategic and operational priorities in a fast paced environment
Strong problem solving and critical thinking skills
Excellent communication, writing, presentation and data organisation skills
Demonstrated interpersonal and leadership qualities
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 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.
