About the job
As the Quality Lead for Santen in the EMEA region, you will serve as the primary quality liaison for our designated Contract Manufacturing Organizations (CMOs) and partners. Your role is essential in ensuring seamless operational quality oversight and coordination for our externally manufactured pharmaceutical and biologic products.
The CMO Quality Lead will collaborate closely with the Senior Manager of CMO Quality to enhance our quality management processes.
Key Responsibilities:
Act as the Single Point of Contact (SPOC) for quality management of assigned CMOs and partners, facilitating effective communication on operational quality matters within the cross-functional CRM team. Ensure timely escalation of any business risks to your line manager.
Support the Product Quality team with deviation handling, investigations, and management of Corrective and Preventive Actions (CAPAs), including follow-ups from CMO audits and representation in relevant meetings as delegated.
Supervise quality aspects of external manufacturing operations, including being present on-site during validations or essential activities, and assist with product transfers and modifications at CMOs.
Contribute to New Product Introduction (NPI) initiatives and territory expansion for externally manufactured products, coordinating change control processes with NPI and Product Quality teams.
Maintain Quality Agreements with CMOs, prepare drafts for review, monitor quality KPIs, and organize CMO Quality Reviews and regular quality meetings, ensuring comprehensive documentation and follow-up on action items.

