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Senior Manager Quality Operations, Waterford
Client:
Morgan McKinley
Location:
Waterford, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
c6e298225d93
Job Views:
77
Posted:
21.01.2025
Expiry Date:
07.03.2025
Job Description:
Job Description
The Senior Manager is responsible for ensuring oversight of activities on-site associated with the manufacture, release and distribution of IMPs and commercial products.
Position Summary:
Reporting to the Associate Director Quality Operations, the Senior Manager is responsible for ensuring oversight of activities on-site associated with the manufacture, release and distribution of IMPs and commercial products.
Responsibilities:
1. Act as designee for the Associate Director, QA in their absence.
2. Provide comprehensive QA and Compliance support to new product introduction, engineering, utilities, supply chain, and material movement (including cold chain) for both clinical and commercial products.
3. Coach and mentor colleagues to promote knowledge sharing.
4. Review batch manufacturing documentation, ensuring documentation, investigations, and reports are reviewed and approved promptly, highlighting and assisting in the resolution of issues commensurate with the level of risk.
5. Provide quality support to manufacturing operations, facilities, validation, and laboratories to ensure compliance with all relevant regulatory requirements for commercial products and investigational medicinal products.
6. Ensure readiness for audits and inspections in the Quality/Operational areas through a program of readiness activities. Lead front room or back room for audits and inspections.
7. Develop initiatives to improve quality standards by actively driving continuous improvement activities in the QA team, delivering efficient QA support to stakeholders and optimized QA review and batch release approval processes.
8. Provide leadership for all people and culture initiatives within the QA team and throughout the Waterford site.
9. Support broader Horizon site Quality Management activities, contributing to Quality and Compliance objective setting and goal attainment.
Qualifications and Skills Required:
1. A minimum of 10 years of relevant experience within the Pharmaceuticals industry or a related field.
2. Strong knowledge of cGMP requirements for pharmaceutical manufacturing.
3. Direct experience in GMP management within a pharmaceutical/biopharmaceutical company is essential, including exposure to the FDA, HPRA, or other authorities of similar standing.
4. Excellent accuracy and attention to detail.
5. Good knowledge of relevant computer packages, e.g., Trackwise, SAP, MES, or similar.
6. Planning and organizing skills are required to plan, execute, and track commitments of Quality Assurance and to adjust to changing priorities.
7. High-level technical skills including analytical, auditing, biopharmaceutical manufacturing, and regulatory inspection management. Technical writing skills are required.
8. Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and in writing.
9. The individual in this position is expected to represent Horizon Therapeutics' interests, objectives, and policies responsibly and professionally.
Morgan McKinley are working in partnership with Horizon Therapeutics
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