Lead and manage the EM team with capacity planning, work schedule prioritization, and optimal resource allocation to ensure an efficient workflow with full synchronization with the Process Unit (manufacturing) while developing training curriculums as needed to assure compliance with Quality, SOP, ICH guidelines, industry standards, and Novartis requirements.
In this role, the selected candidate will establish, monitor and maintain all appropriate quality programs and procedures, testing methodologies and test equipment to assure compliance to specifications and to federal, state, and local regulation for all products.
Mentor and develop personnel, including dedicated succession planning and contingency management. Effectively navigate and lead through the challenges of change and establish global stakeholder engagement focused on win-win solutions.
In this role, you will be responsible for the implementation and management of the Performance Improvement (PI) plan and maintaining compliance with Joint Commission and relevant State and Federal regulations related to quality monitoring and performance improvement.
This position is responsible for providing internal GCP Quality Assurance support, contributing to the establishment and maintenance of OncoMed GCP quality systems, and supporting OncoMed corporate development objectives and timelines by ensuring compliance with quality standards and applicable regulatory requirements.
Represent QA on various projects and support activities associated with manufacturing, testing and release of product including activities managed by Contract Manufacturing Organization (CMO) and Test Laboratories (CTL).