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 *****:****, 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.
#J-*****-Ljbffr