Quality Assurance ManagerThe QA Manager will be the quality lead on development project teams. Responsible for Quality oversight of contract manufacturing organisations (CMOs) and material/service suppliers to ensure that all operations are fully in compliance with current international standards for cGMP. Specifically, this position is responsible for Quality oversight of CMOs/vendors of Biologics Investigational Medicinal Product across all phases of the clinical development lifecycle. Reporting directly to Director, Quality Development Projects.
Quality oversight of Biologics DS and DP process/product development and clinical manufacturing/analytical testing/packaging.
QA Lead on internal and external CMO cross functional teams for development projects
Quality oversight of process and analytical qualification and validation in accordance with phase appropriate regulatory requirements
Monitoring operations at the contract site including batch review and disposition, review of stability data, deviations, OOS investigations, change controls, and other quality systems.
Provide QA support to project teams and participate in strategies for product development and obtaining regulatory approval.
Collaboration with contract manufacturers, packagers and testing laboratories to resolve any quality issues.
Collaboration within cross functional CMC teams to resolve any quality issues.
Ensure compliance with the GxP vendor qualification programme including initial and ongoing qualification
Conducting vendor audits and vendor site visits as required
Assisting in internal audits and company or CMO regulatory agency inspections
Support the product stability program for IMPs
Contribute to the development of quality policies and procedures as required
Generate and maintain Product Specification Files (PSFs), QP declarations, Supply Chain Flows
Review and approval of IMP product artwork/labelling
Support the execution of the internal Quality Management System (QMS) to ensure compliance to all relevant standards within the company.
Support supply chain with on time Quality review and approvals to ensure timely supply of clinical material to trial sites.
Contribute to regulatory submissions
Build authentic relationships with critical suppliers and contract manufacturers and maintain all product-related Quality Technical Agreements (QTA’s).
Participate in and provide critical analysis of business diligence visits.
Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelines
Foster a positive employee relations environment and a culture of continuous improvement and teamwork through the use of good and consistent management principles.
Required/ Education and Licenses
Bachelor’s degree in chemistry, biology or a related discipline
Eligibility to act as a licensed Qualified Person
GMP lead auditing certification
For further information on this QA Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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