Associate Quality Director - Qualified Person

Responsibilities

• Act as Lead Qualified Person (QP), ensuring the compliant release of all batches and overseeing batch documentation.
• Lead and manage the Quality Assurance department, including mentoring QA Team Leads and driving a strong quality culture.
• Own and approve the Quality Management System (QMS) to ensure compliance with regulatory and corporate guidelines.
• Ensure inspection readiness and lead regulatory inspections with authorities such as the FDA and HPRA.
• Oversee key quality processes including Deviations, CAPA management, and Change Control.
• Provide technical quality guidance across the site and support new product introductions (NPI).
• Manage departmental resources, workload, and budget while engaging with global senior stakeholders.
• Develop, coach, and retain QA talent through effective performance management and succession planning.

Requirements

• Extensive experience in sterile pharmaceutical and/or medical device manufacturing.
• Deep expertise in quality systems, including deviations, CAPA, audits, and change control.
• In-depth knowledge of EU GMP (Annex 1 & 16), FDA / 21 CFR (210, 211, 820), and ICH guidelines.
• Proven experience with Part 11 compliance and working with health authorities and notified bodies.
• Strong people leadership and team management experience.
• Excellent communication and stakeholder engagement skills.
• Analytical, solution-oriented mindset with awareness of continuous improvement methodologies like Lean or Six Sigma.

Benefits

• Competitive salary and bonus scheme.
• Excellent career progression opportunities.
• Health insurance and pension.
• Work-life balance initiatives.

About the Company

Viatris is a global healthcare company dedicated to providing access to high-quality medicines for approximately 1 billion patients annually. By combining the strengths of generics and branded products, we aim to empower people worldwide to live healthier at every stage of life.