Global Quality Systems & Compliance Lead

Grifols; Dublin; On-site; EUR 90,000 - 120,000; Full time

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

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.