· The E2E PLCM Product Portfolio Leader of the Product Lifecycle Management group is accountable & responsible for ensuring tactical and operational success for the Change Management process related to FG Global Change Control (GCC) and Artwork for Biogen commercial products.
· Provides leadership to the PLCM E2E Product Leaders & Planners in their management of GCC and Artwork for Biogen commercial products and ensures process alignment and adherence.
· Partners cross-functionally within PO&T and R&D to ensure GCC compliant and patient ready artwork is available to meet our On Time & In Full customer centric commitment. Oversees alignment of artwork with the technical requirements needed for production on a packaging line. As part of this, builds understanding the technical limitations and liaises with key stakeholders on solution, next steps, and mitigation.
· Oversees vendor management with -amongst others- Graphic Service providers and IT partner Global Vision.
· Oversee process interdependencies across the End-to-End Supply Chain and collaborates with Planning, Asset Teams, Commercial, Regulatory Sciences, and Regulatory CMC to ensure that change control and labeling changes align with the FG & DP supply plans, while achieving on-time closure.
· Oversees and/or leads cross-functional project implementation plans for Biogen commercial products for GCC and Artwork, ensuring activities across PO&T departments are aligned and sustained in line with KPIs. This may involve collaboration with the following key stakeholders: Master Data Management, Quality, Regulatory CMC, Manufacturing, Serialization, Distribution & Logistics, Asset Team, Commercial, and Regulatory Sciences.
· Is accountable for a structured way to maintain oversight of market/regional requirement and change management across the globe
· Escalates to Senior Leadership to highlight PLCM implementation risks for Biogen commercial product portfolio.
· Performs capacity planning and project monitoring across the team to ensure compliant, effective, and efficient execution of all changes impacting Finished Goods.
· Is accountable for the continuous improvement roadmap projects related to the above.
Accountability Description
· Leads a PLCM Product portfolio team and ensures appropriate resourcing, skills, capabilities to deliver best in class. Accountable for GCC and Artwork for Biogen commercial products. Builds/Leads an effective and efficient forum structure to lead the cross-functional organization in initiating, prioritizing and executing all product changes.
o Recruits, develops and coaches talent to manage critical business functions.
o Endorse a culture of transparency and communication while driving commitment and compliance across the team.
o Proactively address potential challenges in the internal and external business environment which may affect OTIF commitment.
o Contributes to development and management of AOP for E2E Product leadership
· Champions PLCM End-to-End product and product change management representation across the PO&T organization. Be the go-to contact for the broader organization, like Commercial and Regulatory Sciences
· Leads development of the Artwork and GCC strategic planning for the product portfolio and markets/regions to liaise with internal and external stakeholders, including vendors and CMOs, to ensure alignment
· Identify and communicates risks related to change management to Asset teams and Sr. Leadership, including recommendations and implementation of of corrective actions to ensure compliance and to maintain market implementation due dates.
· Oversees or leads continuous improvement projects to drive process standardization and operational efficiency. Perform Artwork-, GCC and other change management process analyses and identify potential improvement projects.
· Endorses a promote and maintain compliance via exception & CAPA management, while driving on-time closure
Minimum Requirements
· Bachelor or Master Degree in Supply Chain Management, Business Administration, Engineering or similar education required
· Lean Six Sigma/Green Belt is an asset
· Minimum 8-10 years working experience in a Global Supply Chain role, or Product Life Cycle Management role, preferably in change management
· Experience within an international and controlled environment is required
· Must have strong GMP/GXP Skillset.
· Strong analytical, problem solving and communication skills (excellent written and verbal communicator to articulate recommendations and key decision points to senior management)
· Open to learn the impact of change management on commercial business
· Knowledge of printing technologies, artwork creation software, pre-press activities and CMO line manufacturing is an asset. Experience with Supply Chain and LCM tools, preferably: Oracle, TrackWise, Agile PLM
· Influencing and negotiation skills to attain buy-in from different stakeholders