This company is one of the world’s leading biopharmaceutical companies. Through acquisitions and mergers, they have expanded rapidly in their short history and now boast more than 10,000 employees, and offices in more than 40 countries. This organisations growth strategy is to focus on developing and marketing innovative speciality medicines for symptomatic conditions to serve significant unmet patient needs. Their strategic priorities are to drive optimum performance of their existing products, enabling access to these medicines for patients today, and building their pipeline through research and development and business development to deliver future treatment access for patients. Due to continued expansion this organisation are now looking for a Quality Assurance Manager to join their operation in Dublin.
The individual will be responsible for, but not limited to:
- QA oversight of CMOs, Suppliers, QC labs.
- Responsible for management of CMOs & resolution of all quality related issues.
- Represent management in meetings and cross functional teams.
- QA support and management approval of all CMO documentation.
- Development & assessment of quality metrics, CMO trending, KPIs and reports.
- Proactively monitoring the performance of CMOs & suppliers to ensure that they remain in a state of control & implementing necessary improvements.
- Leading, reviewing and approval of deviations, change controls which are related to CMO management.
- Manage quality systems pertaining to CMO management including but not limited to Deviations, Change Controls, CAPAs.
- Management of annual vendor assessments.
- Leading or supporting CMO / Quality projects.
- Leading audits (external).
- The successful QA Manager will have a degree in pharmacy, chemistry, biotech or a related discipline.
- A thorough understanding of quality systems is essential GMP and GDP.
- Experience in Biologics Manufacturing is essential.
- Experience in cell culture, fermentation and purification.
To learn more apply online or contact Preneta Naidoo on +353 1 6321870.
Salary: On Application
Location: Dublin West