Description:
The person in this role will develop and drive the implementation of the Alexion Operations (AO) End-to-End Launch Excellence framework to promote a common approach and processes for handling launches along Small and Large Molecules products with multiple sites and in mixed modality cases (internal AO/AZ site and or CMOs).
The position has end-to-end accountability for all aspects related to Launch Excellence framework development and roll-out and can make / propose the right enterprise tradeoffs.
The person in this role will promote cross functional alignment while developing the End-to-End Launch Excellence framework to ensure shared process knowledge amongst all stakeholders to enable right-first time launches and to offer options to expedite launch timelines.
- Define the scope of the AO End-to-End Launch Excellence framework and drive its development and implementation to enable right-first time launches and to offer options to expedite launch timelines which will include financial and operation impact to the business.
- This includes responsibility for developing and implementing:
- AO Launch Excellence SOP, Work Instructions and/or templates required to standardize the way launches are handled by Alexion Operations
- KPIs/ metrics to measure AO launch readiness
- Identify main workstreams (as well as their deliverables and major milestones) within and outside AO to ensure launch process is covered from end-to-end perspective.
- Provide critical management support and facilitation for launch plans in complex environment.
- Assess the current launch Risk within AO and identify potential risk enablers to destabilize future launch Plans. Develop launch continuity plans which include mitigation Strategy across AO Organization.
- Provide critical management support and facilitation for project requirements in complex, personalized medicines environment.
- Preparing Overview / analysis on the launch plan for the AO SVP to present to the RBU Leadership Team
- Provide support and leadership to assigned workstream leads by establishing a governance and program tracking structures as required for the successful development of the AO end-to-end launch framework.
- Provide ongoing communications to key internal/senior stakeholders involved in the end-to-end launch framework. Keep stakeholders informed of key decisions, changes, risks, and progress to major milestones.
- Launch Excellence representative within AO and for AO as the interface with associates across the business (VISion, Commercial, PROPEL, GPT/GMT), Product Development and Clinical Supply (PDCS), Regulatory CMC, etc…
- Ensure that AO launch framework is understood, accepted, and applied systematically throughout the organization.
- Defines benchmark standards and audit process to ensure compliance with the agreed way of working. Ability to dive deep in the operational process to curse correct underperforming parts as needed.
- Ensure compliance with GMP and regulatory requirements (including record management) and continuous improvement of quality relevant processes within area of responsibility.