About the Role:
This is an opportunity to be part of a pioneering biologics manufacturing facility that's revolutionizing healthcare.
Primary Responsibilities:
* Obtain Qualified Person (QP) certification and release authorization for clinical trial supplies
* Conduct internal audits of Good Manufacturing Practice (GMP) systems/processes and supplier/third-party contractor evaluations
* Provide regulatory advice and oversee agency inspections
* Support start-up activities for Clinical Supply Chain Quality Dublin
* Oversee Manufacturer/Submission Authorisation submissions and maintenance
* Participate in multidisciplinary teams and contribute to strategic initiatives
Requirements:
* Degree in science, engineering, or a related field
* 10+ years of experience in the pharmaceutical industry
* Eligibility to act as a Qualified Person (QP) on the Manufacturing/Importation Authorisation
* Strong knowledge of International Council for Harmonisation (ICH)/GMP, data integrity, and regulatory guidelines
* Proven leadership and influence management skills
* Excellent communication abilities and partnership-building capabilities