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Grifols

Quality Systems, Compliance Manager

Grifols

Manager, Quality Systems & Compliance at Grifols leading quality improvement in healthcare. Ensure conformity with regulatory standards and enhance product quality and patient safety.

Posted 7/22/2026full-timeDublin • 🇮🇪 IrelandMid-LevelSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in Quality Management Systems, GMP compliance, and Data Integrity within regulated environments. Proven ability to lead quality initiatives, manage audits, and implement continuous improvement strategies.

Highest-signal resume keywords
Quality Management SystemsGMP ComplianceData IntegrityChange ControlCorrective and Preventive Actions (CAPA)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Quality Risk ManagementDocument ControlSupplier Quality ManagementTraining ComplianceRegulatory Inspection SupportQuality Data AnalysisQuality System Metrics GenerationSupplier AuditsContinuous ImprovementProject Management
Soft Skills
Analytical Problem-SolvingCommunicationStakeholder ManagementOrganizational SkillsLeadership
Tools & Technologies
Electronic Quality Management SystemsSAP
Industry Keywords
PharmaceuticalBiotechnologyMedical DeviceHealthcare ManufacturingCompliance Assessments

About the role

Key responsibilities & impact
  • Lead and manage the site Data Integrity Programme, including SOP governance, compliance assessments, risk management activities, and site-wide data integrity initiatives.
  • Support the implementation and continuous improvement of the Grifols Quality Systems & Compliance Programme.
  • Ensure compliance with corporate, regulatory, and site requirements.
  • Identify compliance risks and recommend improvements to quality systems and processes.
  • Manage and coordinate key Quality Systems including: Change Control, Deviations, Corrective and Preventive Actions (CAPA), Supplier Quality Management, Supplier Complaints and Supplier Agreements, Documentation Control, Training Compliance, Quality SAP Processes, Other Quality System activities as required.
  • Support compliance activities across the site, including variation submissions, product specification compliance, new product introductions, and implementation of new manufacturing processes.
  • Support site readiness for regulatory inspections, customer audits, and corporate audits.
  • Coordinate and ensure timely completion of corrective actions arising from audits, inspections, and compliance assessments.
  • Participate in investigations of quality system issues and drive effective CAPA implementation.
  • Manage the Documentation Compliance Management (DCM) system.
  • Oversee QMS document archives and records management activities.
  • Generate and communicate site Quality System metrics and compliance reports.
  • Support Site Quality Council activities and Annual Product Review processes.
  • Analyse and trend quality data to identify opportunities for continuous improvement.
  • Support supplier qualification programmes and supplier quality activities.
  • Conduct or support supplier and outsourced provider audits as required.
  • Coordinate site self-inspection programmes and follow-up activities.
  • Support external audit preparation and facilitate audit activities.
  • Partner with Manufacturing, Engineering, Supply Chain, Quality Control, Regulatory Affairs, and other functional groups to resolve quality and compliance issues.
  • Communicate quality and compliance requirements across the site.
  • Identify and share best practices within the organisation and across Grifols manufacturing sites.
  • Deliver or coordinate GMP and quality system training where required.
  • Lead, coach, and develop Quality Systems & Compliance personnel.
  • Foster a culture of accountability, engagement, collaboration, and continuous improvement.

Requirements

What you’ll need
  • Bachelor's degree in Science, Engineering, Pharmacy, Quality, or a related discipline.
  • Significant experience within a regulated pharmaceutical, biotechnology, medical device, or healthcare manufacturing environment.
  • Strong working knowledge of Quality Management Systems and GMP requirements.
  • Experience managing quality systems such as Change Control, Deviations, CAPA, Document Control, Training, and Supplier Quality.
  • Experience supporting regulatory inspections and audit programmes.
  • Previous leadership or people management experience is desirable.
  • Strong understanding of GMP, Quality Risk Management, and Data Integrity requirements.
  • Experience working with electronic Quality Management Systems and SAP.
  • Excellent analytical and problem-solving capabilities.
  • Strong project management and organisational skills.
  • Ability to manage multiple priorities simultaneously.
  • Excellent communication and stakeholder management skills.

Benefits

Comp & perks
  • Highly competitive salary
  • Annual performance-based bonus
  • Share options scheme
  • Group pension scheme with company matching contributions
  • Private Medical Insurance
  • Ongoing opportunities for career development
  • Succession planning and internal promotion opportunities
  • Education assistance
  • Wellness and social activities
  • Collaborative and inclusive working environment