Associate Director Validation

Associate Director, Validation (PCI Ireland)

The Associate Director of Validation will be a key member of the Site Quality Leadership Team at PCI Ireland Pharma Services, responsible for leading all aspects of process, facility, laboratory, and computer system validation to ensure compliance with VMP, HPRA, and FDA requirements.

Key Responsibilities

• Lead the design, strategy and execution of validation programs across facility, laboratory equipment, CSV, processes (packaging and cleaning) and data integrity.
• Communicate validation strategy to site leadership and collaborate with functional departments to ensure VMP is understood and adhered to.
• Define validation KPIs and schedules, managing and reporting through the SQDC model.
• Manage and develop the validation team, including training, coaching, HR activities, and performance appraisals.
• Generate and maintain validation documentation, protocols and reports, ensuring ALCOA+ principles and clear author/approval processes.
• Manage tooling validations and associated documentation.
• Support complaint, deviation, and change control investigations and ad hoc projects as required.
• Identify and support opportunities for process improvement and continual improvement of the validation system.
• Lead Continuous Process Verification initiatives and ensure best practice implementation across sites.
• Participate in the Corporate Centre of Excellence (COE) to share and implement best practices.
• Collaborate with sister sites to provide a consistent PCI experience to customers.

Minimum Qualifications

• Bachelor's or associate degree in Validation, Technical Engineering or a science based subject.
• Minimum 10 years of experience in qualification and process validation.
• Proven experience with QMS systems and project management.
• Experience with HPRA/FDA regulatory requirements and VMP compliance.
• Demonstrated ability to manage multiple tasks, set priorities and meet predefined targets.

Desired Skills & Attributes

• Excellent written and oral communication skills; able to present risk based validation strategies to senior management and customers.
• Strong problem solving, troubleshooting and decision making skills.
• Self motivated, results driven, adaptable, and able to work collaboratively in a fast dynamic environment.
• Proficiency in Microsoft Office (Excel, PowerPoint, Word).
• Customer facing experience with partner and client interactions.
• Ability to travel for business requirements.

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.