Accountability Description
1. Drive timeline activities to support the readiness of the QMS and supporting business processes for the start-up of GMP production in Solothurn.
2. Design, review and maintain Site Master File for the Solothurn site to ensure site GMP readiness as per project timeline.
3. Represent Solothurn Quality within the global quality organization to ensure local implementation of the global QMS. This includes review and approval of electronic log books.
4. Responsible for managing the Quality Risk Register and ensure appropriate risk assessments are in place
5. Ensure site training plan and system for content/documentation are in place and maintained.
The main responsibility of the Sr. Associate II, Quality Systems and Compliance is to serve as site liaison to global functions for documentation, training and corporate quality systems e.g. change control, CAPA and exception management. The Sr. Associate II will also serve as quality point of contact for project managers for other line functions and ensure quality commitments are delivered on time. The Sr. Associate II will help manage the Quality Risk Review Process, at the Solothurn site, work within the team to help manage site governance teams such as Management Review, Deviation Review Board Change Control Review board, QMS implementation, Inspection Readiness and Inspection Management. Project Management experience is required.
The Sr. Associate II, will ensure and lead selected activities to ensure the local implementation of Biogen global quality systems at the Solothurn Site through current state of construction through commissioning, validation, regulatory approval and into daily GMP operations. The realization of these deliverables will culminate in an overarching Quality Plan specific to the operations of the new Solothurn site. An inherent part of the Quality Plan is management of the Quality Risk Register and ensuring identified risk assessments will be authored and in place at right time.