Full job description

Mylan TeorantaViatris 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.
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