Objectives
- Translates implementation Launch /LCM strategy as determined in Product Lifecycle Teams (PLT) to ABR Supply Chain objectives and action plans per designated product group.
- Applies the knowledge, skills, tools and techniques of project management / operational excellence to support timely implementation of product Launches, Variations (CMC & Labeling) and execution of other activities related to the life cycle management of the Amgen products.
Position Specific Tasks
- Assures timely and fully compliant maintenance of the Change Control Management system related to Launch executions, Variations implementations and other activities related to the life cycle management of the Amgen products.
- Ensure Change Controls are implemented following Procedures and Guidance documents (Right First Time)
- Ensure Change controls are implemented against agreed time lines (Milestone adherence)
- Facilitates Product Lifecycle Team (PLT) meetings
- Executes specific Supply Chain projects and business cases (example: SKU’s management, rationalization, and implementation of new pack configuration).
- Owner of the End-to-End Overall Launch Project Plan, with input from Regional Operations Leads (ROLs) and/or Senior Alliance Managers, to support ABR Site related activities.
- Leads Project Management meetings with associated functions in order to support timely and effective Launch execution, Variations implementations and other activities related to the life cycle management of the Amgen products.
- Supports ROLs and/or Senior Alliance Managers in developing project charters, facilitating workshops, etc.
Communication/collaboration:
- Following strategic objectives of ROLs and/or Senior Alliance Managers, the SCPM will assure effective planning, timely execution and implementation of Launches and Variations in coordination, collaboration and leveraging on internal stakeholders such as QA, RA, Production & Site Planning, Artwork, Warehouse, Customer Service & Procurement.
- Reports, communicates and presents metrics on the Launch executions, Variations implementations and other activities related to the life cycle management of biopharmaceutical products.
- Provides key updates to Site and other stakeholders on status of readiness activities and related projects.
Operational Excellence
- Foresees or identifies and analyzes complex problems and opportunities to streamline departmental activities and leads projects to drive improvements.
- Partners with all relevant stakeholders to share and implement best practices.
Qualifications
Minimum Requirements
- Bachelor’s degree or equivalent, Typically 3-5+ years of related professional experience, OR
- Master’s degree or equivalent, Typically >1-3 years of related professional experience, OR
- PhD or equivalent with minimal related professional experience
- Project Management experience
Preferred Requirements
- Experience in Pharmaceutical industry
Interested? Call Daria at d.finikova@panda-int.com or call +31202044502 for more info.