Role & Responsibilities
• The Business Integrator role will work within the Risk Management/Inspection Readiness (RMIR) Pillar of the North America Quality Organization (U.S. and Canada) to help shape and define this role.
• Integrate into the Commercial organization (Patient Support, Pharmacovigilance (PV), Country Quality, Medical, Regulatory, Clinical) as a business partner to proactively identify, navigate, and drive Quality risk discussion and avoidance.
• Assess and prioritize risk, and balance the needs of each country's Business Units (BUs).
• Foster Quality culture and collaboration and translate activities into functional, executable plans including metrics, milestones and timelines.
• Collaborate and engage with multiple BUs (multi-channel engagement) to understand ongoing activities to allow the Quality organization to provide a risk perspective.
• Structure a communications framework, e.g., if formal quarterly meetings, what is the communication plan between meetings for the various stakeholders across the BUs and Quality
• Develop a 'playbook for success' defining key metrics, how to interact with the Business Units (BUs), how to manage specific situations, communication strategy to senior level stakeholders in the BUs, incl. country Counsel.
• Evaluate the GxP processes throughout the operation, and propose dashboard activities for trending which can support various stakeholder communications, action plans, and milestones. The dashboards will help us articulate and present key data collection, and use it to translate risk priorities or areas for focused improvement within the business units.
• Work with two internal client resources who have been engaged with parts of this initiative to share perspectives on what has worked and not worked......draw on your experiences to share approach(es) that have been successful.
• Shape the longer term organizational mindset change and mission, while solidifying excellence in this evolving arena.
Skills
• Seasoned Quality minded professional with Life Sciences experience required, likely 15+ years' experience
• Has demonstrated experience working across business units with senior management
• Demonstrated experience integrating quality risk discussion with commercial operations as defined below
• Risk management and Enterprise risk tolerance experience (Quality risk)
• Commercial business acumen, collaboration, relationship building and negotiating prowess
o Commercial operations related to patient support, e.g., Pharmacovigilance (PV), Country Quality, Medical, Regulatory, Clinical