Hybrid Manager, Quality Assurance – Integrated Systems

at West Pharmaceutical Services

• Job title: Manager, Quality Assurance – Integrated Systems
• 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

• Customer Quality Manager overseeing Quality Management Systems and supplier performance metrics. Ensuring customer quality issues are resolved effectively and compliance is maintained at West Pharmaceutical Services.

Responsibilities

• The primary responsibilities of the Customer Quality Manager, Integrated Systems, involve over-sight of the Quality Management System (QMS), Customer Quality issues, questions / concerns, Customer facing related items and audits as well as overseeing supplier performance metrics and support / drive supplier audits, out of specification (OOS) investigations.
• Lead and drive internal teams to resolve Out of Spec (OOS) quality issues and be the main point of contact for customers on these issues.
• Partners closely with internal stakeholders i.e Operations, Technical Customer Support, Sales, Labs, R&D, and Product Management to ensure that customer quality issues are resolved in a timely manner and the needs of the customer are being met.
• Maintaining and reporting metrics and trends to Senior Management and Extended Leadership Team (ELT) and implementing improvements on a continuous and pro-active basis.
• Generate, manage and oversee customer and supplier quality agreements.
• Ensuring compliance to corporate, regulatory and customer quality standards will be at the forefront of the responsibilities.

Requirements

• BA/BSE in a technical or related field plus 5 years of demonstrated experience in the administration of Quality Systems, or a combination of education and experience.
• Must have 5+ years’ work experience in Medical Device or Pharmaceutical Manufacturing Environment.
• A thorough working knowledge of quality systems such as ISO 15378 /ISO 13485 / 21 CFR Part 820 / EU GMP is essential.
• Accredited lead auditor against recognized quality standards in support of audits
• Have experience in the facilitation of quality risk management coupled with a good working knowledge of ISO14971.
• Experience of hosting regulatory audits from either the European or US authorities
• Must have excellent communication and written skills
• Must be able to work in a fast paced environment.
• Must be able to travel as required by the position.
• Must be able to organize and prioritize tasks, problem solve, must be detail orientated and self-motivated.
• Must be able to work independently on own projects while working concurrently with all departments.

Benefits

• Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.
• Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.
• Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.