Purpose of the Role
* Provide subject matter expertise in EU Good Manufacturing and Distribution Practice (GMDP) internally and externally for clients.
* Lead the GMP and GDP Quality Teams effectively.
* Act as a key contact point for clients (current and new).
* Perform the duties of a Qualified Person (QP) on MIA / MIA-IMP and on client MIAs as required.
* Contribute to the Quality Management Team's strategy and help drive it forward.
* Act as point of contact with authorities, in particular the HPRA.
* Support the company and its clients in fulfilling GMDP responsibilities for quality and quality systems, including providing Qualified Person, Responsible Person, project management, and wider GMDP advice.
Qualifications & Requirements
* Eligible to be named as a Qualified Person on an MIA/MIA-IMP.
* Eligibility as an RP on a WDA(H) (desirable).
* Significant pharmaceutical industry experience with in-depth knowledge of quality systems in a GMDP environment and hosting regulatory inspections.
* Proven experience as a QP with detailed knowledge of GMDP.
* Strong understanding of Quality Management Systems and performance metrics.
* Excellent leadership and communication skills.
* Ability to work cross-functionally, applying relevant quality standards and legislation to meet company and client objectives.