NPI Quality Product Lead - Drive Global Pharma Impact

PCI TRGR Penn Pharmaceutical Services Ltd; Killiney; On-site; EUR 90,000 - 120,000; Full time

Job summary

PCI Pharma Services Ltd in Ireland seeks a Quality Product(s) Lead to oversee the quality elements of New Product Introduction and major programmes for a client. The role requires leading a technical/quality team, ensuring regulatory compliance, and coordinating with customers to deliver on timelines.

The successful candidate will have extensive NPI experience, cGMP knowledge, and the ability to manage cross-functional teams while communicating effectively across site and client levels.

Qualifications

• Demonstrable NPI experience and quality governance.
• Experience with medical devices and pharmaceutical quality.
• Strong knowledge of EU GMP and ISO requirements for medical devices.
• Proven track record leading technical/quality teams.
• Effective communication with customers and management.

Responsibilities

• Oversee quality aspects of New Product Introduction across programmes.
• Collaborate with customers and stakeholders to meet timelines.
• Lead cross-functional teams and manage project quality plans.
• Ensure cGMP compliance and PQS alignment.
• Manage risks and changes within programmes.
• Maintain up-to-date operational documentation.

Skills

NPI governance

Quality leadership

cGMP knowledge

Customer liaison

Project coordination

Risk management

Team management

Documentation control

Regulatory compliance

Stakeholder communication

Education

Master’s degree in Technical/Engineering/Science

EQF level 6 in Technical/Engineering/Science

Tools

Excel

Word

PowerPoint

Project

Visio

Job description

PCI Pharma Services Ltd in Ireland seeks a Quality Product(s) Lead to oversee the quality elements of New Product Introduction and major programmes for a client. The role requires leading a technical/quality team, ensuring regulatory compliance, and coordinating with customers to deliver on timelines.

The successful candidate will have extensive NPI experience, cGMP knowledge, and the ability to manage cross-functional teams while communicating effectively across site and client levels.