Senior Director Global Validation & Compliance

PCI TRGR Penn Pharmaceutical Services Ltd; Killiney; On-site; EUR 120,000 - 160,000; Full time

Job summary

PCI Pharma Services seeks an Associate Director of Validation to lead the implementation and execution of processes across Facility, Laboratory, CSV, and Cleaning at PCI Ireland Pharma Services sites.

You will define the validation strategy, manage a high-performing team, and collaborate with Engineering, Production, and QC to meet regulatory requirements and client expectations. Excellent communication and leadership are essential in this role.

Qualifications

• Excellent communication and presentations skills, both written and oral.
• Proven ability to manage multiple tasks and meet targets.
• Strong risk-based validation strategy and project management capabilities.
• Proactive and collaborative approach with cross-functional teams.

Responsibilities

• Lead validation design, strategy, and compliance for Facility, Laboratory, CSV, and Cleaning.
• Communicate strategy to site leadership and ensure regulatory adherence (HPRA/FDA).
• Define validation KPIs and schedules; manage validation team and HR activities.
• Generate and approve validation templates, protocols, and reports; ensure ALCOA+ documentation.

Skills

Communication skills

Presentation skills

MS Office

Travel willingness

Customer facing

Problem solving

Team leadership

Education

Bachelor's or Associate degree in Validation / Technical Engineering or Science

Tools

Microsoft Office

Job description

PCI Pharma Services seeks an Associate Director of Validation to lead the implementation and execution of processes across Facility, Laboratory, CSV, and Cleaning at PCI Ireland Pharma Services sites.

You will define the validation strategy, manage a high-performing team, and collaborate with Engineering, Production, and QC to meet regulatory requirements and client expectations. Excellent communication and leadership are essential in this role.