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Quality Systems and Compliance Manager

Dublin West, Dublin
Closing date
30 May 2023

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Quality Systems and Compliance Manager

Reporting to the Technical Director, the Quality Systems and Compliance Manager is responsible for management of Documentation Compliance Manager (DCM) and archiving in relation to QMS systems.


What your responsibilities will be:

  • Managing of Change Control system, 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 required.
  • Management of Documentation Compliance Manager (DCM) system
  • Provide Reports to site in relation to Quality Management System (QMS) as required.
  • Provide regular reports on site's metrics to Technical Director
  • Management of Documentation Archive for QMS documentation.
  • Authoring of Standard Operating Procedures (SOP's) in relation to the Documentation System
  • Management and ownership of the Change Control system in GWWO
  • Management of deviations related to Documentation control
  • Management of Annual Product Reports
  • Management of GMP introductory and annual refresher training for all GWWO employees
  • Management of Quality SAP activities
  • Communication with the manufacturing sites of Grifols in relation to QMS activities where appropriate
  • Management of Supplier complaints
  • Provide support ensuring external audit readiness and during external audits and corporate internal audits
  • Ensure new regulations and guidelines are correctly and promptly incorporated into GWWO practice
  • Ensures the corrections of findings, risks and recommendations are promptly and thoroughly incorporated into the quality systems
  • Identifies and shares "Best Practices"
  • Communicate site compliance issues and organise site retraining where require
  • Participate in investigations of quality system issues and drives CAPA implementation to ensure CAPA findings, risks, recommendations, and outcomes are appropriate and are clearly documented and communicated
  • Trends, analyses, and reports on quality data to improve product and process Quality; develop recommendations based on data analyses
  • Oversight of site Training activities
  • Oversight of Regulatory compliance activities


Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily

  • Excellent communication skills
  • Competence in Microsoft packages specifically word, excel and PowerPoint
  • Ability to work proactively on own initiative
  • Excellent technical writing and analytical skills
  • Flexibility
  • Results orientated
  • Process improvement and procedure writing expertise
  • Experience of conducting audits
  • Demonstrated project management experience in leading cross-functional teams
  • Detail oriented, well organized and able to work independently and in teams.
  • Good communication skills both verbal and written
  • Flexible, able to adapt quickly to change in a fast-paced environment
  • Solid problem-solving skills
  • Previous experience in facilitating of health authorities audits
  • Minimum of 5 years' experience in Quality Systems/Quality Assurance environment
  • Excellent understanding of GMP regulations and guidelines
  • Previous experience in managing/supervising
  • Previous experience in facilitating of health authorities audits
  • BSc or MSc in a science, pharmacy or related discipline
  • Experience of leading audits an advantage
  • Certification in auditing will be considered an advantage.
  • Experience in working in aseptic area and understanding of Annex 1 requirements will be considered an advantage.


What we offer

  • It's a brilliant opportunity for someone with the right talents.
  • Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications. We'll help you grow professionally.
  • Flexible schedule
  • Benefits package
  • Contract of Employment: Permanent position

If you're interested in joining our company and you have what it takes, then don't hesitate to apply. We look forward to receiving your application.

Grifols is an equal opportunity employer.


Grifols is a global company that since 1909 has enhanced the health and well-being of people around the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative solutions and services in more than 100 countries.

Grifols Worldwide Operations Ltd. was established in 2013 in Dublin, Ireland. It serves as the management center for the global Bioscience Division overseeing treasury, risk management, supply and demand planning, regulatory, R&D and commercial functions.

It also serves as a hub for labeling, packing, final conditioning and distribution of finished plasma products to Grifols' worldwide network of commercial subsidiaries and distributors, with the exception of Spain and the United States. The site will also host an Albumin purification plant which is now under construction.

Grifols Plant

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