Category: Scientific & Clinical
Job ID: 218479
Date Posted: 04/07/2021
Job Title: Vendor Alliance Project and Risk Management Specialist
The Clinical Trial Business Partnerships (CTBP) department is focused on executing the business’ sourcing strategy across all phases of R&D development operations. This group applies a common framework to drive efficient, consistent and compliant processes for vendor relationship and management of COMPANY’ major clinical service providers. Serving as a bridge between COMPANY’ clinical teams and external services providers, CTBP is responsible for building the appropriate in-house management/oversight structure and mechanisms, while driving the external collaboration with clinical service providers in effort to yield a multitude of innovative ideas to deliver on COMPANY’ goals.
Position Summary / Objective: This role reports to the Associate Director – Vendor Alliance Risk and Project Management Lead and is an integral member of the Global Alliance Management (GAM) team. The role is responsible for working with key stakeholders, internal and external, on behalf of GAM to develop and optimize tools, processes and documentation related to key alliance management business processes, including, but not limited to issue root cause analysis, issue management, CAPAs and TPRM. The role does not have any line management responsibilities.
• Lead and/or support key quality business process within GAM including, but not limited to:
o Audits & inspections
o Quality issue management including root cause analysis, CAPA development and management, effectiveness check management
• Work with the COMPANY TPRM team on behalf of GAM and COMPANY business functions to support key supplier risk management process including, but not limited to:
o Third party risk management (TPRM)
o Supplier category-level Inherent Risk Questionnaire (IRQ) completion
o Support TPRM in the conduct of supplier risk management audits – specifically regarding the remediation of any identified risks
o Ongoing supplier TPRM monitoring plan maintenance
• Collaborate with internal stakeholders (including, but not limited to SS&P/TPRM, GCCCI, GQ-CT&S Audits and Inspections) to participate in any continuous improvement initiatives across COMPANY’s CAPA management process; third party risk management (TPRM) process; and any additional Alliance Management processes as deemed appropriate by Alliance Management leadership.
• Assist with communication and training across GAM to ensure understanding of and adherence to GAMS role in supplier processes including, but not limited to CAPA management; third party risk management (TPRM); and any additional Alliance Management processes as deemed appropriate Alliance Management leadership.
• Liaise, as necessary, with COMPANY suppliers, on behalf of Alliance Management, in relation to processes including, but not limited to CAPA management; third party risk management (TPRM); and any additional Alliance Management processes as deemed appropriate by Alliance Management leadership.
A minimum of a BA or BS Degree in a clinical or scientific discipline
• >7 years industry experience (pharma, biotech, CRO) required; scientific, financial, GxP and business problem solving experience desired
Key Competency Requirements
• Strong Project Management and Stakeholder Management skills
• Alliance management, vendor management experience.
• Experience with managing audit findings, including root cause analysis, CAPA development and management
• Experience with a quality audit management system e.g. Veeva Vault / Infinity
• Change mindset
• Demonstrated ability to effectively communicate to a diverse audience at multiple levels within the company
• Demonstrated ability of managing and working with cross-functional / global cross-country people/teams in a complex, changing environment
Travel Required < 10%