Our leading pharmaceutical client is looking for a Quality Release Manager to join their Quality Operations Department on their Dublin site. This role will report into the site Quality Lead and will be responsible for the development and leadership of the Quality Release Team.
- To ensure timely reporting and escalation of Quality Defects, Stability OOS and Recalls internally and to relevant competent Authorities.
- To ensure efficient and timely review and release of Finished Product batch documentation.
- To set the direction for the department, drive high performance and foster an improvement culture.
- To ensure timely execution and ownership of Batch related Deviations and OOS investigations within Quality Release Dept.
- To ensure standardised Quality processes for Quality Operations systems e.g. Repack Management, Risk Management, TCs, and Reject Management etc.
- Increase efficiencies, e.g., by means of introducing cyclic planning, digitalization and optimal planning.
- To run and be involved with improvement projects on site.
- Overall responsibility for organizational development of the Dublin Quality Release team in consultation with immediate manager and HR by leading and developing the team leaders towards a more LEAN and efficient way of working.
- Work closely together with "Global Quality Laboratories" to ensure that CoAs are flawless and delivered on time in sync with the batch review and release process.
- To be an active member in Global Quality and Quality Operations Leadership team and actively influence the Dublin Site Extended Leadership Team.
- Master of Science in Pharmacy, Chemistry, Chemical Engineering, Microbiology or equivalent.
- 8+ years' experience in Pharma Quality Assurance and 5 years QP release (desirable).
- Strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems is desirable.
- Several years of general management experience, demonstrated strong change management skills & excellent people management and stakeholder management skills.
- Solid understanding of LEAN, planning and standardization.
Contact Richard Butler for a confidential discussion on this role.
Telephone: +353 87 2558528
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