NPI Quality Product Lead – Pharma & Medical Devices

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

Job summary

PCI Pharma Services (Ireland) Ltd in Stamullen, Co. Meath invites a capable Quality Product Lead to drive the quality elements of New Product Introduction and large-scale client programmes.

You will collaborate with customers, align with PCI PQS, and lead multi-disciplinary teams to ensure regulatory compliance from concept through handover. The role requires deep knowledge of cGMP, EU GMP/ISO for medical devices, and proven experience in managing quality projects in pharma or medical device

Qualifications

• Demonstrable experience in New Product Introduction (NPI) and quality governance.
• Experience with medical devices assembly and quality critical activities in pharma/medical device environments.
• Strong knowledge of cGMP and regulatory requirements; EU GMP/ISO familiarity.

Responsibilities

• Ensure compliance with cGMP, PCI PQS, site policies and regulatory requirements.
• Partner with customers to capture records within timelines and escalate when needed.
• Lead cross-functional teams to provide QA guidance and documentation management.
• Ensure instructional documentation is up to date and supports efficient production.
• Be main contact for quality escalations from customers.
• Defining programme strategy with PM and cross-functional teams; monitor timelines and critical paths.
• Manage risks and changes within the programme lifecycle; lead by example in leadership roles.

Skills

NPI experience

Quality governance

Medical device assembly

cGMP knowledge

Customer liaison

Team management

EU GMP knowledge

ISO requirements

Project/Program management

Advanced Excel/MS Office

Education

EQF level 6 in Technical/Engineering/Science

Master’s degree in Technical/Engineering/Science

Tools

Excel

Word

PowerPoint

Project

Visio

Job description

PCI Pharma Services (Ireland) Ltd in Stamullen, Co. Meath invites a capable Quality Product Lead to drive the quality elements of New Product Introduction and large-scale client programmes.

You will collaborate with customers, align with PCI PQS, and lead multi-disciplinary teams to ensure regulatory compliance from concept through handover. The role requires deep knowledge of cGMP, EU GMP/ISO for medical devices, and proven experience in managing quality projects in pharma or medical device