Traceability Delivery Manager

Title : Traceability Delivery Manager

Company : Ipsen Pharma (SAS)

To deliver compliance with Serialization and Traceability regulations by first coordinating the evaluation of new and changed regulations and performing impact assessment of network changes, second by coordinating projects to enable compliance at manufacturing sites, external manufacturers and in the supply chain. The T-COE delivery lead also manages the deployment of continuous improvements and change management for the Serialized supply chain.

Main responsibilities / job expectations

• Delivery Compliance - Evaluate

• Coordinate the impact assessment of markets new serialisation or Track & Trace mandates for Products, Systems & Process changes by leveraging the T-COE stakeholder network

• Coordinate the traceability & serialization impact assessment of Network change projects by leveraging the T-COE stakeholder network. Network change initiatives are projects such as:

• New/changed : Legal entities, 3PL, CMO, Mfg site

• New Product Launch

• Master data changes

• Value-Add initiatives

• Changes driven by Business Unit, Tax and treasury

• Acquisition, divestiture and collaboration

• System deployments- Delivery Compliance - Enable

• Provide cross organizational stakeholder alignment/coordination and aid in mandate enablement and project execution (Enablement, PlayBook, SOP, Training, Communication)

• Integrate new or changed requirements into established Serialisation infrastructure (systems and processes)

• Manage Compliance - Continuous Improvements & Change Management

• Working with the T-COE Operations lead, identify Serialization continuous Improvements (CI) opportunities and coordinate CI projects execution

• Facilitate change management for the Serialization & Traceability scope by identifying impacted supply chain processes, systems and colleagues

• Project Management

• Plan and track specific stakeholder team activities within a project or program

• Analyze and document program risks, issues and, decisions required

• Identify risks and provide proactive mitigation to project/program management

• Coordinate scope between stakeholders and document program progress

• Deliver weekly status reports to project core teams

• Provide regular status reports to management and leadership

• Create and manage success tools for the track program status (Project Plan, Action, Issue Log, Risk

Register, etc.)

Knowledge, abilities & experience

Education / Certifications:

• BA/BS degree in IT, Business Administration, Supply Chain, Engineering or relevant field
• Project management qualification (PMP/Prince2)

Experience :

• 5+ years’ project management experience required preferably in Pharmaceutical environment
• 2+ years’ experience implementing processes and solutions in serialized supply chain
• Experience in developing budgets and tracking budget expenses
• Experience of working with multidisciplinary groups (internal & external), flexibility, adaptability and ability skills to work within a matrix environment.

Languages:

• English required, French is an asset

Key Technical Competencies Required

• Demonstrated experience in Serialization and Traceability projects management
• Knowledgeable of serialized Pharmaceutical supply chain operations (Manufacturing and Logistics)
• Knowledge of serialization regulatory requirement (EUFMD, US DSCSA )
• Excellent planning, organizational and management skills
• Excellent verbal and written communication skills.
• Skills in coordination, risk evaluation and overall project management
• Good leadership skills and capability to work within a team as leader and team player in a matrix environment
• Good computer literacy