Responsible for contributing to key functional, tactical, and operational aspects of the QC EM/UM group at Biogen. Project management, initiation of process improvements, liaison for, qualification and validation activities, modeling the leadership competencies, aiding in the development of peers and performing QC approval, as required. Proficient in their understanding of Quality Systems and apply that knowledge in coaching and continuous improvements of systems cross-functionally. Ensuring adherence to all regulatory licenses and regulations, serving as a subject matter expert in multiple disciplines, interfacing with key customers. Provide technical support during audits/inspections. Support management for activities related to compliance with policies, providing feedback for personnel development, effective and timely decision making/corrective actions on the floor. Able to work effectively, independently and within a team framework, across all business areas and levels of the organization.
The Quality organization at the new Solothurn site is envisioned to be supported by team members with diverse backgrounds that are capable of cross functional work to support the high throughput design of the facility. As the site moves through the design phase into operational readiness, Quality staff will be focused on incorporating a new operations strategy into the quality management systems, lab systems and business systems. The operational strategy strongly relies on the incorporation of online real-time monitoring, automation of routine testing wherever possible and integrated information technology systems to bring transparency to routine business operations. As such, experience with electronic batch records and integrated sampling plans would be of advantage.