We are seeking a highly experienced and strategic Qualified Person/Responsible Person to join our dynamic Clinical Supply Chain Quality team in Dublin. In this pivotal leadership role, you will be responsible for the QP certification and batch release of clinical supplies, acting as the Responsible Person or Pre-Approval Access under our WDA.
You will be a key point of contact for quality and compliance across the supply chain, providing expert advice to stakeholders and ensuring adherence to the highest global regulatory standards. This role offers the opportunity to shape our quality strategy, influence regulatory interactions, and drive continuous improvement initiatives within a complex and critical environment.
Your responsibilities will include:
- QP certification and batch release of clinical supplies.
- Acting as the Responsible Person (RP) on our Wholesale Distribution Authorisation (WDA) for Pre-Approval Access.
- Leading and supporting Health Authority GMP/GDP inspections and audits across the supply chain.
- Providing expert guidance on quality issue management, process enhancement, and compliance.
- Incorporating global regulatory trends and changes into Supply Chain Quality.
- Maintaining the Site Master File and Manufacturers Authorisation.
- Ensuring rapid communication of critical quality issues to relevant stakeholders and senior management.
- Reviewing and approving procedural documents.
- Leading and participating in multidisciplinary and cross-functional work/project teams.
- Providing guidance and setting expectations for global regulatory execution across the business.
- Proactively identifying and mitigating quality risk areas.
- Contributing to the development of global audit plans.
- Undertaking continuous professional development to maintain QP/RP status and industry expertise.
- Championing and supporting OPEX programs and continuous quality improvement initiatives.
To excel in this leadership role, you will need:
- A degree in science, engineering, or a related discipline is essential.
- Must be eligible to act as a Qualified Person (QP) on the Manufacturing/Importation Authorisation.
- A minimum of 10 years' experience in a significant role within the biopharmaceutical/pharmaceutical industry.
- Previous experience as a Responsible Person (RP) on a WDA is preferred.
- Demonstrated expert knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes, and principles of Quality Assurance.
- A proven track record of building and maintaining high-performance teams/organizations and effectively influencing global teams to achieve results.
- Exceptional leadership and influence management skills with the ability to foster strong partnerships across a matrix organization.
- Proven clear and impactful communication skills.
- A demonstrated ability to foster a culture of continuous improvement.
