Associate Director Validation

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. This role will be a key member of the Site Quality Leadership Team that influences the wider organisation by demonstrating leadership through actions, accountability coaching and development of the Validation Team, Quality, and function departments validation work closely with. The role of the Associate Director Validation is to lead the implementation and execution tasks relating to Process, Facility, Laboratory, Computer System Validation (CSV), Cleaning and Equipment Development at PCI Ireland Pharma Services sites.

Responsibilities

Lead the implementation and execution tasks relating to Process, Facility, Laboratory, Computer System Validation (CSV), Cleaning and Equipment Development at PCI Ireland Pharma Services sites; Responsible for PCI Ireland validation design, strategy, compliance, and overall adherence to VMP; Communicating the strategy to site leadership and working closely with all functional departments to ensure the VMP is understood and ultimately adhered to; Ensuring all validation activities on site relating to Facility, Laboratory Equipment, CSV, Processes (packaging and cleaning), and Data Integrity meet client expectations and regulatory requirements (HPRA/FDA); Define Validation KPI’s and validation schedule. Utilise SQDC to manage operations for validation and provide weekly summary of SQDC outputs to Quality Director; Manage, train, develop, coach the validation team on the validation system, documenting, and execution. Manage HR related activities. Complete Quantum for Team and yourself in a timely manner ensuring 1:1 conversation happen on time and team is aware for expectations; Key member of the site leadership team. Flag concerns with site validation, work with other departments (Engineering, Production, NPI, QC and others) to ensure validation needs are understood; Member of Corporate Centre of Excellence (COE) ensuring best practices are shared and implemented. Work closely with sister sites to ensure One PCI experience is demonstrated to customers; Ensure periodic review and annual validation plan is in place and adhered to. Report slippages through SQDC model. Introduce Continuous Process Verification in line with best practice; Generate validation template protocols for new and existing computer systems, facilities, equipment and processes and review/approve all reports. Ensure protocols designed around maximising equipment CSV capability ALCOA+ principles; Generate and maintain documentation for cleaning validation performed at PCI sites in Ireland in line with current best industry practice; Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions; Manage tooling validations and associated documentation; Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation; Support complaint investigations, deviation investigations and change controls as required; Undertake such tasks and manage specific or ad hoc projects as and when required to meet business needs; Identify and support opportunities for improving processes and/or procedures; Be a Leader, continue to drive good practice (cultural and technical) across the site, and continually improve the validation system

Requirements

Bachelor’s or associate degree in Validation / Technical Engineering or Science based subject; + 10 years' experience working in Validation across Qualifications and Process Validation; Excellent communication and presentations skills, both written and oral – ability to present risk-based project validation strategy in a clear and concise manner to the Business Unit Planners, Customers and where required, to Senior Management; QMS system experience necessary; Proven track record of showing how results were delivered through project management; Capability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets; Ability to manage multiple tasks and set priorities; Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems; Self-motivated with a results driven approach; Adaptable and ability to work collaboratively; Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.); Some travel required for business requirements; Customer facing experience; Adaptability: Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints; Passion for Results: Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles; Decision Making: Identify and understand issues, problems and opportunities whilst providing; Strong insight into Pharma/Medical Device guidelines relating to regulatory and quality requirements