Associate Director Validation
Core
Lead the implementation and execution of Process, Facility, Laboratory, Computer System Validation (CSV), Cleaning, and Equipment Development at PCI Ireland Pharma Services sites.
Role type
Associate Director Validation
Builds
Validated pharmaceutical facilities, laboratories, computer systems, and processes for biopharma clients.
Domain
Biopharma / Pharmaceutical Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process Validation, Computer System Validation (CSV), Cleaning Validation, Quality Management Systems (QMS), Risk Methodology, Project Management, Data Integrity (ALCOA+), Regulatory Compliance (HPRA/FDA), Team Leadership, Protocol Generation, Change Control Management, Deviation Investigation, Continuous Process Verification
Preferred skills
Experience with SQDC systems, Experience with Quantum performance management tools, Experience with Corporate Center of Excellence (COE) collaboration
Technologies
Microsoft Office (Excel, PowerPoint, Word), SQDC, Quantum
Responsibilities
Define Validation KPIs and schedules; manage and coach the validation team; generate and approve validation protocols and reports; ensure adherence to validation master plans and regulatory requirements; support complaint, deviation, and change control investigations; drive continuous improvement in validation systems.
Seniority
Senior, hands-on IC with leadership responsibilities
