To act as the Santen Quality interface for assigned Contract Manufacturing Organizations (CMOs) and partners in EMEA, ensuring effective operational quality oversight and coordination for externally manufactured pharmaceutical products and biologic products.
The CMO Manager Lead will work closely with the Sr Manager CMO Lead.
What you will do
Coordinate and support quality management of assigned CMOs and partners, acting as the Single Point of Contact (SPOC) for operational quality topics within the cross-functional CRM team, ensuring effective triage, communication with accountable Product Quality owners, and timely escalation of business risks to the line manager.
Provide support to the Product Quality team for deviation, investigation, and CAPA management, including follow-up of CAPAs from CMO audits, representation of Quality in relevant forums as delegated, and support during regulatory inspections under senior QA guidance.
Oversee quality aspects of external manufacturing operations, including on-site QA presence for validations or activities requiring independent witness when applicable, and support product transfers, line changes, new packaging lines, and other manufacturing changes at CMOs under supervision.
Contribute to New Product Introduction (NPI) and territory expansion activities for externally manufactured products, coordinating change control activities with NPI and Product Quality teams.
Maintain and update Quality Agreements with CMOs, prepare drafts and revisions for review and approval, support implementation and monitoring of quality KPIs, prepare inputs for CMO Quality Reviews and annual risk management activities, and organize and coordinate regular quality meetings including agenda preparation, documentation, action tracking, and follow-up.