QA Specialist, External Manufacturing

2 weeks ago


Liverpool, United Kingdom Seqirus A CSL Company Full time

The CMO QA Specialist will be a member of the CMO QA team responsible for Quality Assurance oversight of a Contract Manufacturing Organizations (CMO) in Europe. The Specialist will be the Single Point of Contact (SPOC) for their CMO, providing strategic and technical expertise for all cGMP related matters, including assurance that all aspects comply with cGMP, legal, regulatory and Seqirus requirements.
- This individual is responsible for the collaborative oversight of all Seqirus products (cell & derived, vial and syringe, drug product and drug substance) manufactured at their appointed CMO. This individual will be expected to make QA decisions for their assigned CMO, with escalation to the Director CMO QA when needed.
- This role will work collaboratively with the wider CMO QA team to establish a partnership with the Seqirus Key Account Manager(s), MS&T and all other relevant departments, which have oversight and responsibility for the production of Seqirus products in CMOs.
- European travel required for pre-campaign readiness and post campaign Continuous Campaign Improvement (CCI) meetings. Adhoc travel will be required during the manufacturing campaign to facilitate expedient issue oversight and resolution (estimated


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