Global Quality Operations Leader

PCI Pharma Services; Stamullen; On-site; EUR 95,000 - 135,000; Full time

Job summary

PCI Pharma Services is seeking an experienced Quality leader to drive quality excellence across the business unit. The role centers on comprehensive governance of quality processes, documentation standards, and regulatory compliance, serving as the primary liaison for key customer relationships and quality initiatives.

You will lead a quality operations team, develop cross-site training, and partner with QA peers to optimize quality systems and drive continuous improvement while maintaining

Qualifications

• Minimum 10 years’ experience in Quality for a pharmaceutical company operating to EU GMP standards.
• 2-5 years’ experience in a leadership or team management role.
• Broad understanding of EudraLex Vol 4, its key chapters and annexes.
• Understanding of serialization requirements.
• Strong communication skills and leadership abilities.
• Ability to train and develop others and engage with internal/external stakeholders.

Responsibilities

• Lead quality operations and oversee batch manufacturing record generation and review.
• Partner with peer Quality Managers to drive QA optimization and continuous improvement.
• Establish cross-functional quality training frameworks across sites.
• Govern quality documentation systems, updates, and record maintenance.
• Oversee deviation management and investigation protocols with swift resolutions.
• Ensure adherence to GMP standards and customer quality agreements.

Skills

Quality leadership

GMP knowledge

Regulatory compliance

Cross-functional leadership

Quality systems

Deviation management

Job description

PCI Pharma Services is seeking an experienced Quality leader to drive quality excellence across the business unit. The role centers on comprehensive governance of quality processes, documentation standards, and regulatory compliance, serving as the primary liaison for key customer relationships and quality initiatives.

You will lead a quality operations team, develop cross-site training, and partner with QA peers to optimize quality systems and drive continuous improvement while maintaining