Senior Specialist, Quality, Integrated Systems

3 weeks ago

Waterford, Waterford, Ireland West Pharmaceutical Services Full time

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Senior Specialist, Quality, Integrated Systems, Waterford

Client: West Pharmaceutical Services

Location: Waterford, Ireland

Job Category: Other

EU work permit required: Yes

Job Reference: e90eafc8055d

Job Views: 4

Posted: 12.08.2025

Expiry Date: 26.09.2025

Job Description:

Job Summary

In this role, you will provide quality direction, governance, and best practices across the Quality Management System and supported programs. You will oversee multiple projects to ensure compliance throughout the product lifecycle, support and maintain the QMS, and ensure product quality and patient safety through effective quality processes. Activities include product testing, batch review, investigations, CAPAs, customer complaint handling, training, document control, change management, audits, and supplier corrections.

You may also ensure supplier compliance, lead supply chain quality improvements, and collaborate with cross-functional teams to implement quality system improvements.

Essential Duties and Responsibilities

  • Lead project planning, develop project plans, identify risks, and implement mitigation strategies.
  • Coordinate project execution with cross-functional teams.
  • Provide quality guidance to ensure compliance with regulatory and cGMP requirements.
  • Review and approve design and manufacturing documentation.
  • Support risk analysis and hazard assessments.
  • Lead QMS activities including CAPA, investigations, audits, document control, and change management.
  • Drive continuous improvement in products, services, and processes.
  • Develop design control deliverables and quality records.
  • Support quality assurance activities to improve customer experience.

Education

  • Bachelor's Degree in Engineering or Science or equivalent experience required.

Work Experience

  • Minimum 5 years in a regulated industry (e.g., Medical Device), including manufacturing and post-market activities.
  • At least 4 years of independent project management experience in regulated environments.
  • Deep knowledge of cGMP, ISO 15378, ISO 13485, 21 CFR 820, ISO 14971.
  • Proficiency with project management and statistical software, Microsoft Office, Windows OS.

Preferred Knowledge, Skills, and Abilities

  • Experience with MasterControl, SAP, SharePoint.
  • Knowledge of ISO 11040, ISO 11607.
  • Expertise in quality management tools and standards (APQP, PPAP, MSA, SQC).
  • Strong project management skills and communication abilities.

License and Certifications

  • Six Sigma Green or Black Belt (preferred).
  • Certified Quality Technician (CQE or CQA, preferred).
  • ISO 13485/15378/9001 Auditor or Lead Auditor certification (preferred).

Travel Requirements

Up to 10% (~26 days per year).

Physical Requirements

Sedentary work involving minimal physical exertion.

Additional Requirements

  • Strong commitment to quality and safety.
  • Excellent communication and attention to detail.
  • Ability to multi-task, work independently, and solve problems.
  • Adaptability to change and effective teamwork skills.
  • Ability to make sound judgments and comply with SOPs and safety policies.
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