Associate Director Validation

About the Role

Join PCI Pharma Services as an Associate Director of Validation at our Stamullen, County Meath site in Ireland. This key leadership role involves steering validation activities across Process, Facility, Laboratory, Computer System Validation (CSV), Cleaning, and Equipment Development for PCI Ireland Pharma Services sites. You will be an integral member of the Site Quality Leadership Team, shaping strategy, ensuring compliance, and leading the validation team to meet both regulatory and client expectations.

Main Responsibilities

• Lead the design, strategy, compliance, and adherence of the Validation Master Plan (VMP) for PCI Ireland.
• Effectively communicate validation strategy to site leadership and collaborate across functional departments to ensure full understanding and compliance with VMP.
• Ensure validation activities related to Facility, Laboratory Equipment, CSV, Packaging and Cleaning Processes, and Data Integrity comply with client expectations and regulatory standards such as HPRA and FDA.
• Define and monitor Validation KPIs and schedule; apply SQDC methods to track validation operations and report weekly to the Quality Director.
• Manage the validation team by providing training, development, coaching, and performance management including timely Quantum reviews and 1:1 discussions.
• Collaborate with departments including Engineering, Production, NPI, QC to align validation needs, applying risk-based methodologies and pragmatic solutions for compliance.
• Participate in the Corporate Centre of Excellence to exchange and implement best practices and maintain a unified PCI customer experience.
• Ensure regular review and adherence to the annual validation plan, report any issues via SQDC, and introduce Continuous Process Verification in line with industry best practices.
• Create and approve validation protocol templates for new/existing computer systems, facilities, equipment, and processes, ensuring clarity on roles, responsibilities, and adherence to ALCOA+ principles.
• Develop and maintain documentation for cleaning validation aligned with current industry standards.
• Conduct validation activities with minimal supervision in coordination with Technical, Production, and Engineering teams.
• Oversee tooling validations and manage related documentation.
• Guarantee strict compliance with validation procedures and timely completion of required documentation.
• Support investigations into complaints, deviations, and change controls as necessary.
• Manage ad hoc projects and tasks that align with business needs and your capabilities.
• Identify and promote opportunities for process or procedural improvements.
• Provide leadership to maintain and enhance good cultural and technical practices across the site and drive continuous validation system improvement.

Required Qualifications and Experience

• Degree in Validation, Technical Engineering, or a Science-related discipline.
• Over 10 years of experience in Validation, including Qualifications and Process Validation.
• Strong communication and presentation skills to effectively deliver risk-based validation strategies to diverse stakeholders including senior management.
• Experience with Quality Management Systems (QMS).
• Proven project management capabilities demonstrating successful outcome delivery.
• Effective at setting and following clear objectives and ensuring progress to meet targets.
• Ability to prioritize and manage multiple tasks efficiently.
• Strong problem-solving and troubleshooting orientation with a proactive mindset.
• Self-driven with a results-focused and adaptive approach in dynamic environments.
• Proficiency with Microsoft Office suite including Excel, PowerPoint, and Word.
• Willingness to travel as required by business needs.
• Experience in customer-facing roles.
• Ability to adapt in fast-paced and changing environments promptly.
• Passion for delivering results under pressure with a proactive, action-oriented mindset.
• Sound decision-making skills identifying issues and opportunities.
• Comprehensive understanding of pharmaceutical and medical device regulatory and quality guidelines.

Equal Opportunity Statement

PCI Pharma Services is an equal opportunity employer, committed to fostering an inclusive environment free from unlawful discrimination. We embrace diversity and strive for fairness and respect at all organizational levels.