Global GMP Quality Operations Leader

PCI TRGR Penn Pharmaceutical Services Ltd; Killiney; Presencial; EUR 120 000 - 150 000; Tempo integral

Resumo da oferta

PCI Pharma Services is seeking an operational quality leader to own quality processes, documentation standards, and regulatory compliance across the business unit. The role serves as the primary quality liaison for key customer relationships and critical initiatives.

You will lead a quality operations team, drive continuous improvement, ensure GMP compliance, and partner with QA managers to optimize systems and training across sites.

Qualificações

• Minimum of 10 years in quality in pharma under EU GMP.
• 2–5 years in a leadership/management role.
• Strong understanding of EudraLex Vol 4 and its chapters/annexes.
• Knowledge of serialisation requirements.
• Excellent communication with internal/external customers at senior level.

Responsabilidades

• Lead quality operations strategy and oversee batch record generation and QA.
• Collaborate with Quality Managers and Quality Systems Manager to drive QA optimization and continuous improvement.
• Establish cross-functional quality training frameworks across sites to ensure resilience and scalability.
• Govern quality documentation, deviation management, and investigation protocols; ensure swift resolution of issues and customer satisfaction.
• Ensure GMP compliance and adherence to customer quality agreements; position PCI as a trusted partner.
• Direct a quality operations team (~10 direct reports) with performance management and development initiatives.
• Conduct GEMBA leadership walks to assess standards, oversee GMP compliance, and improve housekeeping.
• Lead customer and supplier audits and drive process improvements and product quality initiatives.
• Develop deep technical expertise in packaging and quality processes and provide audit support.

Conhecimentos

Quality leadership

GMP compliance

EU GMP knowledge

EudraLex Vol 4

Serialisation knowledge

Stakeholder management

Cross-functional collaboration

Training & capability development

Problem solving

Multitasking

Descrição da oferta de emprego

PCI Pharma Services is seeking an operational quality leader to own quality processes, documentation standards, and regulatory compliance across the business unit. The role serves as the primary quality liaison for key customer relationships and critical initiatives.

You will lead a quality operations team, drive continuous improvement, ensure GMP compliance, and partner with QA managers to optimize systems and training across sites.