Quality Operations Associate

We are seeking a Quality Operations Associate to serve as the primary interface between Opterion, Contract Development and Manufacturing Organizations (CDMOs), and external vendors to ensure consistent GMP-compliant and release of manufactured batches. The role ensures batch compliance by coordinating quality activities across internal stakeholders and external vendors, including oversight of batch documentation (e.g., batch records, deviations, investigations, and CAPAs) and ensuring timely, complete, and inspection-ready quality records.
This position is also responsible for managing Opterion's electronic document management systems (eDMS), including user access, training support, document control workflows, and change management within the system. The Associate ensures the eDMS remains in a validated state through controlled updates, periodic reviews, and maintenance of validation documentation, working with IT and system vendors as needed. This position reports into the Head of ...