- Expiry Date: 21 January 2022
Actual Job Title: Vendor Oversight Process Manager
Providing guidance and support activities within Global Development Operations [GDO] to team members for all vendor oversight processes
Support standardization of vendor oversight requirements and reporting
Training of all processes related to vendor oversight for involved staff to ensure adherence and efficient execution of activities.
Drive communication and training for GDO vendor oversight, assessment, and due diligence
Manage stakeholder engagement among cross-functional groups, as well as vendors to ensure team attendance / assistance / expertise providing help with a proactive attitude in supporting the team
Communicate clearly and concisely with all levels of organization
Contribute expertise and support for internal and external governance meetings and quality councils exhibiting the ability to support issue management and escalation
Improve existing methods / establishing and embedding best practices for current SOPs
Exhibit ability to update SOPs/guidance documents
Exhibit ability to support ongoing vendor oversight and documentation across Clinical Trial Business Partnerships [CTBP]
Support Vendor audit/inspection Corrective and Preventative Action [CAPA] response & management.
Drive efficient and effective meetings
Support other groups within GDO as necessary
Support GVOO Team with other tasks, as needed
Bachelor’s degree required
At least 5years of relevant pharmaceutical industry experience, with demonstrated comprehensive understanding of clinical trial operations and management of vendors specializing in various service categories such as CROs, Labs, eCoA, IRT, etc.
Demonstrated good working knowledge of GxP and associated vendor oversight requirements and documentation
At least 5 years of demonstrated ability to define projects, to translate work into actionable plans,
Ability to effectively implement and manage projects, to meet key milestones bringing to successful conclusion
At least 5 years of a demonstrated track record of leading through influence, working across complex, global organizational matrices
Demonstrated quantifiable experience in change management and process improvement
Demonstrated ability to communicate, manage and work with cross-functional / teams in a complex, rapidly-changing, and complex, work- environment
Ability to define and balance priorities and multiple [sometimes competing] demands in a responsive and professional manner
Ability to recognize situational implications and ability to escalate and apprise leadership of status/issues
Proficient in the use of MS Office 365 suite including Excel OneNote and MS SharePoint; MS Visio and MS Project.
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