Mylan TeorantaAt 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; andPartnership – 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 DoingAs the Director of Quality Assurance, you will provide strategic oversight of all quality assurance activities within a sterile manufacturing facility. You will ensure that all products meet internal and external quality standards, comply with current Good Manufacturing Practices (cGMP), and fulfill all regulatory and customer requirements—while maintaining the highest levels of safety, quality, and operational efficiency.In this leadership role, you will oversee two critical functions within the QA organization: the Batch Release Team and the Investigations & Corrective and Preventive Actions (CAPA) Team. You will be accountable for ensuring that drug products are released in full compliance with regulatory requirements and internal quality standards. Additionally, you will drive timely and effective investigations, as well as robust CAPA implementation, to support continuous improvement and inspection readiness.We are looking for a proven leader with a strong track record in people management and team development. The successful candidate will be responsible for building and nurturing high-performing teams, and for fostering a culture of collaboration, accountability, and continuous improvement across the QA organization.Every day, we rise to the challenge to make a difference and here’s how the Director of Quality Assurance role will make an impact: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.Manage 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 manualsCollaborate cross-functionally with Manufacturing, 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.Perform other duties and responsibilities as assigned to support departmental and organizational goalsAbout Your Skills & ExperienceFor this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:Bachelor's 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 strategiesMinimum 10 years of experience in the pharmaceutical industry with a strong understanding of sterile drug manufacture and cGMP requirementsDemonstrated ability to manage multiple strategic and operational priorities in a fast paced environmentStrong problem solving and critical thinking skillsExcellent communication, writing, presentation and data organisation skillsDemonstrated interpersonal and leadership qualitiesQP certification a distinct advantageAt 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.Why 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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.Diversity & Inclusion at ViatrisAt 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-InclusionSustainability at ViatrisCorporate 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-responsibilityAt 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.
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