This innovator is a growing biotechnology company focused on the discovery, development and commercialisation of novel therapeutics to treat unmet diseases specifically in the area of neurodegenerative illness with the potential to fundamentally change the course of devastating neurological disorders. With an advancing pipeline of therapeutic candidates for numerous indications and novel targets including Parkinson's disease, this business is entering into an extremely promising and exciting period in its timeline. As a result of expansion, a new requirement has arisen for a Director of EU Quality to join its expanding team here in Dublin.
- Lead and strategically interface with the Technical Operations team responsible for GMP and GDP oversite of CMO's. Responsibilities include vendor interface, vendor audits, product disposition activities, and progressing the associated GMP and GDP elements of the organisations Quality Management System.
- Responsible for managing GMP change controls internal to the business and from CMOs.
- Development, reporting, and analysis of associated Quality metrics.
- Review clinical and commercial enabling regulatory submissions and facilitate responses to Regulatory Agencies for any submission inquiries or inspection findings as required.
- Stay abreast of changes in European and FDA regulations, directives and guidelines, and determine the impact on GMP, GDP operations, and deliverables. Maintain comprehensive knowledge of applicable regulatory requirements and their interpretation.
- Build and foster collaborative relationships with key stakeholders across the business.
- In conjunction with the Quality Head, promote an engaged quality culture across the organisation and contribute to management reviews taking into consideration GMP and GDP quality metrics, results of internal audits and external inspections, industry trends, and the external regulatory environment.
- Provide leadership and guidance in the timely communication/escalation to the Quality Head and Management of issues associated with regulatory compliance.
- Assure a state of compliance and readiness for Health Authority inspections and internal audits.
- Build and lead a team of engaged quality professionals.
- 10+ years of experience in the pharmaceutical industry, with 5+ years of experience directing multiple Quality Management functions and staff including such areas as; QMS leadership, GMP/GDP management, risk management, vendor management, inspection readiness and recruiting, managing and developing high-performance teams.
- Bachelor's degree in a scientific discipline, with an advanced degree, preferred.
- QP certification preferred.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.