Quality Systems & Compliance Manager

Grifols, S.A; Dublin; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Share options scheme

Group pension with company matching

Private Medical Insurance

Education assistance

Wellness and social activities

Job summary

Grifols in Dublin seeks a Manager to lead the site's Quality Systems & Compliance programme, ensuring conformity with regulatory and corporate requirements and protecting patient safety.

You will oversee QMS processes, data integrity, regulatory inspections, and cross-functional collaboration. The role includes driving CAPA, training, and supplier quality activities to sustain a high standard of quality across the site.

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy or related discipline.
• Significant experience in a regulated pharmaceutical/biotech/healthcare manufacturing environment.
• Strong knowledge of GMP requirements and data integrity principles.
• Experience managing quality systems including Change Control, Deviations, CAPA, Document Control, Training, and Supplier Quality.
• Experience supporting regulatory inspections and audit programmes.
• Previous leadership experience is desirable.

Responsibilities

• Lead and advance the site's Quality Management System and Compliance programme.
• Oversee Data Integrity activities and SOP governance across the site.
• Support regulatory inspections, audits and corrective actions.
• Coordinate cross-functional activities with Manufacturing, Engineering, Regulatory Affairs and Supply Chain.
• Coach and develop Quality Systems & Compliance personnel and promote a culture of accountability and continuous improvement.

Skills

GMP knowledge

Data Integrity

Leadership

Communication

Multi-priority management

Education

Bachelor's degree in Science, Engineering, Pharmacy

Tools

SAP

QMS software

Job description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

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 site's 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 You'll 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, 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

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.
• 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 You’ll Bring

Education & Experience

• 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.
• 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

Location

Grange Castle International Business Park, Clondalkin, Dublin, Ireland