Quality Systems & Compliance Manager

Grifols

Dublin

On-site

EUR 90,000 - 120,000

Full time

14 days+

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Benefits offered by this job

Highly competitive salary

Annual performance-based bonus

Share options scheme

Group pension with company matching

Private Medical Insurance

Career development opportunities

Wellness and social activities

Collaborative and inclusive working环境

Job summary

Grifols seeks a Manager, Quality Systems & Compliance to lead the site's quality programmes and drive continuous improvement. You will oversee data integrity, audits, CAPA, and documentation control while supporting regulatory inspections and cross-functional collaboration.

The role requires strong GMP knowledge, leadership experience, and a proven track record in quality systems management within the pharmaceutical/biotech sector.

Qualifications

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 audits.
Previous leadership or people management experience is desirable.
Technical skills: 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.

Responsibilities

Lead and manage the site Data Integrity Programme, including SOP governance and risk management.
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 across Change Control, Deviations, CAPA, Documentation Control, Training and Supplier Quality.
Coordinate supplier quality activities and audits, including supplier qualifications.
Support regulatory inspections and audit readiness and CAPA closure.
Generate and communicate site Quality System metrics and reports.
Collaborate with Manufacturing, Engineering, Supply Chain, Regulatory Affairs and others to resolve issues.

Skills

GMP knowledge

QMS management

Data integrity

Regulatory inspections

CAPA management

Documentation control

SAP experience

Cross-functional leadership

Problem solving

Project management

Education

Bachelor's degree in Life Sciences

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.
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 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 Skills 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.