Project Quality & Risk Lead II serves as primary project quality expert, point of contact and support to project team leadership throughout the project. Manage the Quality Evaluation (QE) workflow. Communicate results to the project team (PL, FLs). Provide support with quality issue management, audits and inspections, and project quality and risk consultancy as required. Assess operational execution using a risk-based approach to verify adherence to standards and assist with remediation when required. Facilitate quality related interactions with clients.
Perform, report, and coordinate the quality evaluations for assigned projects
o Verify compliance with GxP guidelines/regulations, PAREXEL procedures and requirements, and sponsor requirements
o Actively participate in key internal project team meetings and facilitate quality discussions during these meetings
o Schedule and lead the project related Quality Forums
o Attend client meetings with project team leadership to collaborate with and participate in discussions related to quality
o Provide quality advice to the project teams and participate in relevant project team training
o Provide support with investigation of Quality Issues (QIs) and support of QI management including classification of issues, assist in determination of root cause and consultation on appropriateness of corrective and preventive actions
o Provide audit and inspection support for assigned projects, including, where feasible, advising the project team during preparation and conduct of audits and inspections as per applicable SOPs. Review and provide feedback on project related audit/inspection responses generated by project team members per applicable SOPs
Represent Quality Management in audits and inspections as required.
Mentor Project Quality & Risk Leads, as assigned
o Fulfill the mentor role for Project Quality & Risk Leads, as assigned
o Provide consultancy and guidance to Project Quality & Risk Leads, as assigned
Build and maintain relationships with clients / act as primary point of contact for communications with client quality representatives
Fulfill role of Portfolio Quality Lead, as assigned
Serve as quality consultant for assigned accounts to senior project leadership personnel and assist with the oversight of quality aspects of the client program
o Review key portfolio documentation from a quality standpoint
o Provide support and consultancy for portfolio quality issue
o Facilitate portfolio level compliance with the Corrective and Preventive Actions (CAPA)
o Coordinate Project Quality & Risk Leads assigned to the client as needed
o Provide audit and inspection support for portfolio, including, where feasible, advising the project teams during preparation and conduct of audits and inspections as per applicable SOPs. Review and provide feedback on portfolio related audit/inspection responses generated by project team members per applicable SOPs. Represent Quality Management in audits and inspections as assigned.
o Oversee the collection and reporting of portfolio quality metrics. Evaluate the quality status of a portfolio by reviewing applicable quality metrics.
Identify process improvement opportunities
o Oversee the collection
o Report process gaps and participate in implementation of process improvement when required.
• Excellent interpersonal, verbal and written communication skills
• Client focused approach to work
• Substantial clinical trials experience
• Leadership and/or project management skills
• Ability to handle several highly complex projects simultaneously and entire programs, potentially spanning multiple strategic business units (SBUs)
• Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills
• Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
• IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions
• Ability to travel approximately 30% – 50%.
Knowledge and Experience:
• Relevant experience (e.g., in the pharmaceutical or CRO industry).
• English proficiency (written and oral English)
• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience.