Social network you want to login/join with:
Quality Systems and Compliance Associate Director, Dublin
Client:
Grifols
Location:
Dublin, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
8a29e6bf68c7
Job Views:
8
Posted:
19.08.2025
Expiry Date:
03.10.2025
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
Reporting to the Technical Director, the Quality Systems and Compliance Associate Director is responsible for managing the Quality Systems and Compliance responsibilities, including Change Control system, Deviations and CAPA system, Supplier Qualification Process and Supplier Complaints, Quality SAP process, oversight of Quality Compliance, and other activities related to QMS. Contribution to the continuous improvement of the Quality Management System is also expected. Additional duties may be assigned by the Technical Director from time to time if required.
What you will be doing
* Lead implementation of value-added Quality Management System (QMS) improvements in collaboration with global stakeholders to achieve the company’s strategic Quality priorities.
* Provide strategic and tactical direction for Quality Systems design and maintenance.
* Manage key site quality systems such as Change Control, Deviations, CAPAs, Product Quality Reviews, Internal Auditing, Site Quality Reviews, Document Management and Control, Labeling Artwork Approval, Technical Agreements, Supplier Management, Material Qualification, and Site Master File.
* Measure and report site performance on key indicators of these quality systems through metrics.
* Ensure quality system performance is appropriately communicated throughout the site. Provide guidance and assessments on other site Quality Systems.
* Ensure site compliance with HPRA, Food and Drug Administration, and other regulatory authority regulations, as appropriate.
* Develop and sustain a culture of constant site readiness for inspections. Identify industry trends and strategies to keep the site ahead of compliance requirements.
* Identify, assess, communicate, manage, and mitigate quality system risks.
* Lead Change Control Review Boards (CCRBs) and drive CCRB improvement and standardization globally.
* Evaluate new or revised regulations for compliance gaps and support remediation efforts.
* Represent QS&C function on business development and integration projects.
* Create and update procedural documentation and work instructions with clarity and accuracy.
* Support GMP and GDP audits and inspections.
* Develop a support/service mentality in Quality staff, partnering with local departments.
* Serve as a key participant in site regulatory inspections.
* Support daily activities, ensuring QA personnel follow SOPs and cGMP guidelines.
* Develop and coordinate Data Integrity standards and procedures.
* Build staff capability through coaching, mentoring, performance recognition, and career development.
* Maintain accountability for team performance metrics supporting operational and strategic objectives.
* Provide hands-on training, support, and coaching to reports.
* Enforce cGMP, safety, and security procedures, maintaining a safe working environment and reporting incidents promptly.
What you bring to the role
* Competence in Microsoft Word, Excel, and PowerPoint.
* Proactive work approach and initiative.
* Excellent technical writing and analytical skills.
* Flexibility and results orientation.
* Process improvement and procedure writing expertise.
* Experience conducting audits.
* Project management experience leading cross-functional teams.
* Ability to plan, prioritize, and manage shifting workloads.
* Knowledge of global GxP requirements for quality systems, drugs, and devices.
* Experience with change controls, deviations, and CAPAs oversight.
* Strong communication and interpersonal skills.
* Experience managing global projects with multiple locations.
* Facility start-up experience.
* Ability to work in an office environment, using computers, engaging in communications, and collaborating.
* Previous management/supervisory experience.
* Experience facilitating health authorities’ audits.
* 10+ years’ experience in Quality Systems within the pharmaceutical industry.
* Bachelor’s degree in a technical or life sciences discipline.
* Proven ability to work in a high-paced, goal-driven organization and achieve targets.
Our Benefits Include:
* Highly competitive salary
* Group pension scheme with company matching contributions
* Private Medical Insurance
* Opportunities for career development
* Succession planning and internal promotions
* Wellness activities and social events
We encourage everyone who meets the qualifications to apply – we're excited to hear from you.
#J-18808-Ljbffr