As a Quality Release Associate Manager, you will report to the Quality Release Manager. The successful candidate will be a demonstrated self-starter with a proactive, hands-on approach, possessing excellent interpersonal, decision-making, team work, and communication skills. The candidate will be capable of delivering to tight and often multiple deadlines in a dynamic, challenging work environment.
To ensure efficient and timely review and release of Finished Product batch documentation.
To manage and coordinate release activities across all business units, including management of Tier 1 Process and escalations to Tier 2
To report Quality Metris/KPIs to ensure OTIF and ensure right first time (RFT) improvement plans are active.
To ensure timely execution and ownership of Batch related TCs and Deviations within Quality Release Dept.
To coach and develop the Quality Specialists to enable good decision making occurs in real time.
Increase efficiencies, e.g., by means of introducing capacity management through manning boards, digitalization and optimal planning.
To set the direction for the department, drive high performance and foster an improvement culture.
To run and be involved with improvement projects on site.
Overall responsible for organizational development of the Dublin Quality Release team in consultation with immediate manager and HR.
Lead and develop 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.
Be an active member in Global Quality and Quality Operations Leadership team.
Actively influence the Dublin Site Extended Leadership Team
Qualifications & Experience:
Master of Science in Pharmacy, Chemistry, Chemical Engineering, Microbiology or equivalent.
Minimum 5 years’ experience in Pharma Quality Assurance and 3 years QP release (desirable). Strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems is desirable.
General management experience, demonstrated strong change management skills & excellent people management and stakeholder management skills.
Solid understanding of LEAN, planning and standardization.
Must be result oriented, able to set and communicate goals and expectations, be self-driven and ambitious as well as being fuelled by driving improvements.