Vendor Alliance Lead Associate Director (Cardiac Safety and Diagnostics)

Job Description Summary

The Vendor Alliance Lead (VAL) is responsible for the management of outsourced clinical activities and deliverables of one or more supported External Relationship Management Teams (ERMT).
• Working within a matrix environment, the VAL is accountable for all operational aspects of 1 or more ERMTs
• May manage a team of Vendor Startup Managers (VSM) including assignment of trial level support, and as a point of escalation in addition to people management responsibilities.
• Supplier Service or Equipment expert for the assigned services within the ERMTs to drive value beyond cost from Novartis’ external supplier base
• Supporting the implementation of the agreed outsourcing program strategies
• Responsible for supplier governance, management and issue management/escalation across global GCO and locally and cross-divisionally as required (e.g. Country, NIBR, etc.).
• Function as a point of escalation for supplier issues which cannot be resolved at the individual Clinical Trial Teams level
• Leverage knowledge, experience and understanding of service category(s) and suppliers to provide support to the operational management within the ERMT(s)
• Lead supplier due diligence activities with ERMT

 

Job Description

Major accountabilities:

• Lead business review meetings with vendors based on KPI, KQI and UVP dashboards

• Lead and/or support internal cross-functional ERMT meetings

• May lead team of Vendor Startup Managers (VSM) to support supplier startup activities

• Manages escalated global vendor issues, or selected country vendor issues

• Identifies systemic patterns, driving root cause analysis and sustainably and effectively addresses pain points

• Using technological enablers to drive automated and systematic near-time issue resolution

• Function as category expert providing expertise and training to stakeholders

• Ensures compliance with all required SOPs and business guidance documents

• Provides Health Authority inspection support

• CAPA management from audit & inspections

• Drives value through process improvement and innovation within category

• Proactive risk management within category

• Supporting global and local vendor qualification if required

• Supports Vendor Start-up Managers (VSM) in collaboration with the SSU-teams

Key performance indicators:

• ERMT(s) meeting business objectives

• Robust processes to capture and measure the resolution, escalation, and communication of supplier quality/performance issues

• Highly integrated and seen as supplier experts within ERMTs, CTTs and Franchise teams

• No deviations to Novartis specifications and Standard Operating Procedures; Supplier due diligence activities (qualifications and re-qualifications) are completed in a timely manner to minimize any delays to study startup timelines and non-compliance

• Contribute to continuous improvements/enhancements to benefit business community

• Complete and accurate documentation to facilitate successful internal and external audit / inspections

• Timely oversight, completion, and management of assigned supplier qualification and re-qualification requirements

• Accountable for quality and completeness of qualification and governance documentation in VPG systems including ERMT meeting minutes

• Manage and maintain due diligence document templates and tools

Minimum Requirements:
Education:

• Advanced degree in science or business with equivalent experience

Work Experience:

• 5+ years working experience and excellent knowledge of the clinical operation processes and vendor management

• Excellent knowledge of GxP and ICH regulations

• Expert knowledge of clinical trial design and mapping to supplier requirements

• Thorough and technical understanding of Novartis specifications for supplier provided services

• Demonstrated leadership with supplier relationship management and/or expert knowledge of specific service areas

• Demonstrated partnering across divisions with internal and external stakeholders

• Demonstrated root cause analysis, problem solving, and solution generation skills

• History of successfully working in a cross-functional global team and proven ability to function in matrix structure organization

• Leadership to deliver projects according to required and deliverables

• Excellent influencing and communication skills

• Experience or expertise in one or more of Vendor Management Role accountabilities (e.g. global process ownership, business system owner, SOP & FMR management, global training on supplier related SOPs and processes)

Skills:

• Budget Management.

• Clinical Trials.

• Negotiation Skills.

• People Management.

• Process Improvement.

• Project Management.

• Project Planning.

• Vendor Management.

Languages :

• Fluent English, oral and written

 

Skills Desired

Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Model