An exciting opportunity for an Associated Director, Quality Assurance to lead the QMS strategy for a Global Biologics company in Ireland. You will be responsible for ensuring the implementation and adherence to cGMP quality systems in compliance with regulatory, cGMP, and company requirements. Your role is crucial in maintaining the highest level of quality, ensuring continuous compliance and GMP audit readiness. You will establish monitoring and measurement structures. As part of the Quality Assurance team, you will collaborate closely with other departments to support all GMP activities, including QA Operations and QP functions.
Overview of your responsibilities:
Collaborate with functional departments to develop SOPs.
Audit quality documents of functional departments as per GMP requirements.
Responsible for the self-inspection program and Health Authority inspection readiness.
Conduct routine audits of GMP areas, including manufacturing, quality control, and warehousing.
Review and approve generated documents, such as qualification plans/reports, SOPs, deviations, CAPA, change control, QRM, etc.
Ensure compliance of quality systems (e.g., Trackwise, LIMS, SAP) with EU, FDA, and company standards.
Train and develop team members to meet the demands of the company's rapid growth.
Manage a team of 5 employees.
Knowledge, Skills and Experience Required for the Role:
Degree qualification in Vaccine/Biopharmaceutical Science (QP qualification would be advantageous).
Strong demonstrated experience in Vaccine/Biopharma or similar pharma/science background within an EU or FDA regulated environment,
Experience in Quality Management Systems, pharmaceutical regulations, and continuous/process improvement tools.
Demonstrated leadership competencies with at least 5 years of management experience.
Strong knowledge of cGxP requirements and regulations.
Proficiency in troubleshooting and problem-solving techniques, such as formal root cause analysis (e.g., Ishikawa diagrams, FMEA).
In-depth knowledge of QMS and continuous/process improvement tools.
Strong familiarity with EU and FDA regulatory requirements.
For a confidential discussion and more information on the role contact Courtney Russell
+353 (0) 71 9108062