Associate Quality Director - Qualified Person

Posted 16 days 14 hours ago by 1100 Mylan Pharmaceuticals Inc.

Permanent
Full Time
Other
Galway, Galway, Ireland
Job Description

The Associate Quality Director / QP is responsible for administration of the Quality Management System at Mylan Teoranta (A Viatris Company), ensuring products are manufactured according to all applicable regulatory and corporate guidelines. The role manages the QA department, serves as the Management Representative per ISO 13485:2016, and reports directly to the Associate Quality Director II/ QP.

The Role & What You Will Be Doing
  • QP & Batch Release
    • Act as Lead QP, ensuring compliant release of all batches.
    • Oversee batch release processes and review batch documentation for accuracy and compliance.
    • Collaborate with production to resolve release issues and maintain timelines.
  • Quality Leadership
    • Lead and manage the Quality Assurance department, including mentoring QA Team Leads.
    • Own and approve the Quality Management System (QMS).
    • Drive a strong quality culture and continuous improvement mindset across the site.
  • Compliance & Audits
    • Ensure inspection readiness and lead regulatory inspections (e.g. FDA, HPRA).
    • Manage audits and responses with regulatory bodies, customers, and corporate teams.
    • Stay current with evolving regulatory requirements and implement necessary updates.
  • Quality Systems Oversight
    • Own key quality processes including deviations, non conformance CAPA management, change control, and supplier quality.
    • Support new product introduction (NPI) and product launches from a quality perspective.
  • Stakeholder & Operational Management
    • Provide technical quality guidance across the site.
    • Influence decision making to ensure compliant, risk based outcomes.
    • Manage resources, workload, and departmental budget.
    • Engage with senior stakeholders at a global level.
  • People Leadership
    • Develop, coach, and retain QA talent.
    • Drive performance management, capability development, and succession planning.
About Your Skills & Experience
  • Strong experience in sterile pharmaceutical and/or medical device manufacturing.
  • Deep expertise across quality systems (deviations, CAPA, audits, change control, supplier quality).
  • In-depth knowledge of global regulatory requirements, including EU GMP (Annex 1 & Annex 16), FDA / 21 CFR (210, 211, 820), ICH guidelines, and Part 11 compliance.
  • Proven experience working with health authorities and notified bodies.
  • Strong people leadership and team management experience.
  • Excellent communication and stakeholder engagement skills.
  • Ability to work in a fast paced, complex environment and manage multiple priorities.
  • Analytical, solution oriented mindset with continuous improvement (Lean / Six Sigma) awareness.
  • High level of decision making confidence and influence.
Benefits at Viatris
  • Competitive salaries and benefits.
  • Excellent career progression opportunities.
  • Work life balance initiatives.
  • Bonus scheme.
  • Health insurance.
  • Pension.

Viatris is an Equal Opportunity Employer.