Hybrid Manager, Quality Systems and Compliance

at West Pharmaceutical Services

• Job title: Manager, Quality Systems and Compliance
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Waterford, Ireland

About the role

• Manage quality systems and compliance activities for West Pharmaceutical Services. Overseeing audit management and continuous improvement of processes while ensuring compliance with quality standards in Ireland.

Responsibilities

• Manage the day-to-day planning and supervision of quality systems activities including quality systems availability, audit management, customer feedback and enterprise management system quality master data.
• Ensure continuous improvement of processes to ensure quality product and customer service.
• Site QA Manager designee for QA Systems and customer engagement activities.
• Customer and Regulatory audit support Hosting Audits.
• Monitor trends in association with quality systems use and effectiveness (Deviation, CAPA, Change Control, Periodic Documentation Review etc.).
• Ensure GMP training of site personnel in relation to systems use and audit practices.
• Perform QA Sys Engineer tasks as required.
• Identify and develop opportunities to improve existing processes and procedures in line with corporate and customer requirements.

Requirements

• Bachelor's Degree in Quality/ Engineering/Science or business systems.
• Minimum 5 years’ experience preferably in a high volume GMP environment in a Quality Assurance/Quality System function.
• Must have a thorough understanding of ISO 9001 and/or ISO 15378, ISO 13485, cGMP quality management processes.
• Customer feedback and audit management experience.
• Must have thorough understanding of enterprise and document management system requirements.
• Prior Supervisory experience is an advantage.
• Lean/Six Sigma principles.
• Audit Management.
• Quality Risk based thinking and decision making.
• Must have excellent communication skills both oral and written.
• Must be able to prioritize and organize tasks using shared systems.
• Regulatory training is an advantage.
• Problem solving including root cause failure analysis methods.
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point.

Benefits

• Performance-based bonuses
• Service recognition
• Employee appreciation initiatives
• Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives.