Senior Director, Quality Operations & Compliance

Viatris; Galway; On-site; EUR 150,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus scheme

Job summary

Viatris Galway seeks an experienced Director of Quality Operations to strengthen the quality culture across the site. Reporting to the Senior Director of Quality Operations, you will provide strategic leadership across key quality functions, ensuring products meet the highest standards of quality, safety and compliance.

You will lead QP, Batch Release and CAPA programs, oversee QA systems, drive inspections and audits, and mentor high-performing teams to enable safe, compliant medicines globally.

Qualifications

• Bachelors in Pharmacy, Chemistry, Microbiology or related field; advanced degree preferred.
• QP Certified a distinct advantage.
• Strong knowledge of Annex I, US, and EMA GMP regulations.
• Aseptic manufacturing expertise and contamination control experience.
• 10+ years in the pharmaceutical industry with sterile drug manufacture and cGMP

Responsibilities

• Lead and align QP, Batch Release and Investigations/CAPA teams.
• Provide strategic and operational quality leadership to Galway site.
• Oversee product release processes and change control activities.
• Drive regulatory inspections and audit readiness.
• Manage documentation control for batch records and SOPs.
• Collaborate with Manufacturing, Packaging, QC, R&D, Regulatory, Supply Chain.
• Monitor and report quality metrics to senior leadership.
• Develop and mentor QA team toward high performance.
• Act as Senior Director designee when needed.

Skills

Leadership

Regulatory knowledge

Quality Assurance

Problem solving

Education

BSc in Pharmacy

MS/PhD/MBA

Job description

Viatris Galway seeks an experienced Director of Quality Operations to strengthen the quality culture across the site. Reporting to the Senior Director of Quality Operations, you will provide strategic leadership across key quality functions, ensuring products meet the highest standards of quality, safety and compliance.

You will lead QP, Batch Release and CAPA programs, oversee QA systems, drive inspections and audits, and mentor high-performing teams to enable safe, compliant medicines globally.