Quality Systems & Compliance Manager

At Grifols we believe that diversity adds value to our business our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

Position Summary

The Manager Quality Systems & Compliance is responsible for leading and continuously improving the sites Quality Systems and Compliance programme to ensure conformity with applicable regulatory corporate and site requirements. The role will drive a culture of quality and compliance across the organisation while supporting business objectives and minimizing operational disruptions.

The successful candidate will provide leadership for key Quality Management System (QMS) processes oversee data integrity activities support regulatory inspections and audits and work cross-functionally to ensure the highest standards of product quality compliance and patient safety.

What Youll Do

Quality Systems & Compliance Leadership

• 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.
• Quality Management System (QMS) Oversight
• Manage and coordinate key Quality Systems including:Change Control DeviationsCorrective and Preventive Actions (CAPA)Supplier Quality Management
  Supplier Complaints and Supplier AgreementsDocumentation ControlTraining ComplianceQuality SAP ProcessesOther Quality System activities as required

Compliance & Regulatory Support

• 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.

Documentation & Reporting:

• 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.
• Supplier & Audit Management
• 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.
• Cross-Functional Leadership
• 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.

What Youll Bring
Education & Experience

• Bachelors 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.
• Technical SkillsStrong 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.

Our Benefits Include :

• 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

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to applywere excited to hear from you.

Location: Grange Castle International Business Park Clondalkin Dublin Ireland.

Location:Grange Castle International Business Park Clondalkin Dublin Ireland

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