Our client is a leading global healthcare organisation with a significant international footprint, employing tens of thousands of people across multiple continents and generating multi‑billion‑dollar annual revenues.
The company specialises in the development and manufacture of critical therapies, with a particular focus on hospital‑based treatments, sterile manufacturing, and life‑sustaining medicines used in acute and chronic care settings. With a long‑standing reputation for quality, innovation, and patient safety, the organisation operates a network of highly regulated manufacturing facilities worldwide, supplying essential products to healthcare systems and providers globally.
Based at the organisations state of the art manufacturing plant in Dublin, an exciting opportunity has arisen for a Site Quality Manager/Head to lead all Quality operations for the site.
Responsibilities
Ensure the site follows Good Manufacturing Practice for Medicinal Products for Human Use. This is according to Eudralex Volume 4 of "The rules governing medicinal products in the European Union." Follow Commission Directive 2003/94/EEC, its amendments, and any organisational requirements.
Lead all aspects of the product release process including the QP group. Ensure strict adherence to regulatory and customer requirements.
Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and any potential product quality issues.
Develop and maintain an internal review process to ensure continuous compliance, preparing the site for audits at any time.
Lead and manage the audit process for the facility, ensuring that audit findings are thoroughly investigated and addressed promptly.
Measure and analyze site quality metrics and indicators, comparing performance against targets, and implement data‑driven actions for continuous improvement of processes and products.
Develop and implement risk management strategies to minimize product and process risks, ensuring patient safety.
Coordinate the management, execution, and approval of quality documents and records for the site, including Nonconformance investigations, CAPA plans, Change Controls, SOPs, Validation Protocols, and Reports.
Experience
10+ years' experience of Quality or similar role in the Pharma or Biotech industry.
Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments would be advantageous.
Aseptic manufacturing experience with knowledge in Sterility assurance and risk management would be beneficial.
Proven leadership experience with a track record of consistently meeting results.
Ability to operate effectively in a fast‑paced environment and prioritize multiple tasks.
Proven ability to manage/supervise a large and diverse team of employees.
QP eligibility is essential.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.
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