The Technical Manager will be responsible for initiating and managing change control across all stages of product manufacturing for multiple manufacturing sites.
Key responsibilities will be build of change control documentation utilizing the TrackWise change management system and continuous tracking of change approval/implementation progress in order to meet aggressive project timelines.
The role provides an opportunity to work across sites and functional areas and develop experience working with a diverse, global, cross-functional team to ensure product supply to patients.
Search string: Pharmaceutical experience in Change Management,Systems, Trackwise quality, global and GMP documentation, understanding of CMC (Chemistry Manufacturing and Controls)
minimum of 3-5 years with a BS; 1-3 years with MS
Essential Job Functions:
o Partner cross-functionally with operations and development stakeholders to support development of implementation plan for global post-approval changes
o Work with CMC PM and key stakeholders to develop detailed implantation timelines
o Build and manage changes using the TrackWise change management system, drive changes through approval and implementation through detailed tracking of status and remaining deliverables.
o Work with CMC team and internal and external stakeholders to ensure implementation to plan
o Provide updates on status to Operations CMC team as required.
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