· The Global Change Control (GCC) Planner is a member of the Global Master Data & Change Control Team within the Product Life Cycle Management group and is responsible for ownership and project management of GCC’s for Labeling changes, Product & Country launch changes and Drug Substance (DS) & Drug Product (DP) changes impacting Finished Goods (FG). Including opportunities for cross-functional work in the MDM space.
· Actively collaborates with the Global End to End Planning group to ensure that GCC related activities align with the FG & DP supply plans, while achieving Regulatory and Launch implementation due dates.
· The role develops and executes cross-functional project implementation plans for GCC’s with moderate complexity and ensures that activities across PO&T departments are aligned. This typically involves close collaboration with the following stakeholders: Global Artwork Services, Master data management, Quality Assurance, Regulatory (Labeling & CMC), Internal Manufacturing, External Manufacturing, Serialization, Logistics, Asset Team.
· Manages the efficient flow of the GCC process and acts as a key resource and escalation point to Management to highlight GCC implementation risks. Recommends and implements corrective actions to ensure regulatory & quality compliance, and actively monitors adherence to GCC implementation due dates.
Supports cross functional analysis of moderate complexity and supports process improvement for the GCC process.
Accountability Description
1. Own and project manage Global Change Control (GCC) records with moderate complexity for Labeling changes, Product & country launch changes, and Drug Product (DP) changes impacting Finished Goods (FG). Determine when the activities that are documented in the GCC record need to be completed and project manage deliverables in close cooperation with internal and external stakeholders (FG planning team, DS/DP planning team, Global Artwork Services, Master data management, Quality Assurance, Regulatory (Labeling & CMC), Internal Manufacturing, External Manufacturing, Serialization).
2. Balance assigned total workload associated with GCC’s across departments, identify process bottlenecks and work with internal and external stakeholders to resolve issues. Including supporting the MDM team in case of workload peaks require.
Identify and communicate GCC implementation risks to management and recommend and implement corrective actions to ensure regulatory & quality compliance, and to maintain GCC implementation due dates.
3. Support continuous improvement projects to drive process standardization and efficiency improvement of the GCC process.
Provide supply chain / GCC process analyses and identify potential solutions for improvement projects. (e.g. launch readiness for Distributor Markets).
4. Ensure compliance. Work with Quality Assurance to promote and maintain compliance. Exceptions handling/Investigate deviations, determine root causes, implement CAPAs and drive closure.