1. Own and project manage Global Change Control (GCC) records 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)
Work with Subject Matter Experts (SME’s) to ensure that solutions are developed for new requirements specified in a GCC.
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) Support scenario analysis for product Life Cycle Management events (launches, Labeling & CMC regulatory approvals) in close cooperation with the FG and DP/DS planners. (e.g. shifts in country Regulatory approval timelines for CMC changes)
4. Ensure compliance. Work with Quality Assurance to promote and maintain compliance. Exceptions handling/Investigate deviations, determine root causes, implement CAPAs and drive closure.
- Bachelor or Master Degree in Supply Chain Management, Business Administration, Engineering or similar education required
- APICS certification (or equivalent) preferred
- Lean Six Sigma/Green Belt is an asset
- Minimum 5 years working experience in a Demand & Supply Planning or Product Life Cycle Management role with a minimum of 2 years of experience in a similar position
- Experience within an international and controlled environment is required
- Strong analytical, problem solving and communication skills (excellent written and verbal communicator to articulate recommendations and key decision points to senior management)
- Demonstrated experience reducing complex subjects to key points. Ability to work in fast paced environments and great organizational skills to effectively balance a broad range of projects and tasks in parallel
- Exceptional team player (direct and participate in cross-functional and management teams)
- Experience with MRP Demand and Supply Planning is preferred
- Experience with Supply Chain and LCM tools, preferably: Oracle, TrackWise, Agile PLM
- Project Management experience and ability to work in cross-functional teams
- The Senior 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. Has in-depth understanding of process interdependencies across the end-to-end supply chain from DS to FG.
- The role develops and executes cross-functional project implementation plans for GCC’s 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 and supports process improvement for the GCC process. Establishes and implements standard practices, processes and procedures.