Change Control and Quality System Specialist

The incumbent will assist in the management of change controls for the CMC regulatory affairs group for all biological, plasma and/or small molecule products. This will include formulating and implementing CMC regulatory strategies with the global regulatory and international regulatory leads. This person will also assist with other quality system events which require regulatory CMC support (such as deviations, annual reports, inspections/audits, etc.) and act as a liaison with the Tech Ops organization.

Primary role includes:

• Provide collaborative support for execution of global change control strategies to US and other regions (EU & International)

• Quality system support and Tech Ops liaison

• Provide support to other HA interactions as required

• Essential Functions

• Represent CMC regulatory affairs as the change control coordinator for CMC regulatory and key contact (30%)

• Collaborate and communicate with global CMC leads, EU and international regulatory colleagues to provide consistent, clear and timely assessments into the change control management system (50%)

• Assist with supporting other quality system events (20%)