West Pharmaceutical Services

Manager, Quality Assurance – Integrated Systems

West Pharmaceutical Services

full-time

Posted on:

Location Type: Hybrid

Location: Waterford • Ireland

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About the role

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality Management System (QMS)ISO 15378ISO 1348521 CFR Part 820EU GMPISO 14971Quality risk managementSupplier auditsOut of Specification (OOS) investigationsQuality agreements
Soft Skills
Communication skillsWritten skillsOrganizational skillsProblem solvingDetail orientedSelf-motivatedAbility to work independentlyAbility to work in a fast paced environmentPrioritization skillsTeam leadership
Certifications
Accredited lead auditor