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. Coaching and mentoring colleagues to promote knowledge sharing.
4. Review batch manufacturing documentation, and ensures 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 we operate in compliance with all relevant regulatory requirements for commercial products and investigational medicinal products
6. Ensures readiness for Audits and Inspections in the Quality/Operational areas through a program of readiness activities. Leads Front room or back room for Audits and Inspections
7. Develops initiatives to improve quality standards via actively driving continuous improvement activities in the QA team which delivers efficient QA Support to stakeholders and optimised QA review and batch release approval processes.
8. Provides leadership for all people and culture initiatives within the QA team and throughout the Waterford site.
9. Supports broader Horizon site Quality Management activities which include contributing to Quality and Compliance objective setting and goal attainment.
Qualifications and Skills Required:
10. A minimum of 10 years of relevant experience within the Pharmaceuticals industry or a related field.
11. Strong knowledge of cGMP requirements for pharmaceutical manufacturing required.
12. Direct experience in GMP management within a pharmaceutical /biopharmaceutical company is essential and will include exposure to the FDA, HPRA or other authorities of similar standing.
13. Excellent accuracy and attention to detail.
14. Good knowledge of relevant computer packages e.g. Trackwise, SAP, MES or similar.
15. Planning and organising skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
16. High-level technical skills including analytical, auditing, biopharmaceutical manufacturing and regulatory inspection management. Technical writing skills are required.
17. Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
18. 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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