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Quality Management Opportunities at Parexel

By being hired into one of our Quality Management jobs at Parexel International, you’ll be a key member of the Parexel International team. Professionals in Quality careers come from a variety of backgrounds, bringing an assortment of knowledge and skills to every area of our business. A job in Quality at Parexel International may be waiting for you!

Senior Project Quality & Risk Lead

Job ID 59565BR Singapore, Singapore, Singapore
Primary project quality expert and support to project team leadership throughout the project. Manage the Quality Evaluation (QE) workflow. Work with the Functional Quality Leads (FQLs) if applicable on execution of the QEs to proactively identify and address potential quality risks or issues across the project. Communicate results to the project team (PL, FLs). Act as the primary point of contact for the project team in regards to quality. Provide primary support with quality issues, audits and inspections, and consultancy as required. Mentor Project Quality Leads I and II, as assigned. • Verify compliance with GxP guidelines/regulations, Parexel procedures and requirements, and sponsor requirements• Actively participate in key internal project team meetings and facilitate quality discussions during these meetings.• Schedule and lead the project related Quality Forums.• Attend client meetings with project team leadership to collaborate with and participate in discussions related to quality.• Provide quality advice to the project teams.• Participate in relevant project team training.• Provide support with investigation of Quality Issues (QIs) and support of QI management including classification of issues, consultation on appropriateness of corrective and preventive actions.• 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.• Evaluate the quality status of a project by reviewing applicable project quality metrics.• Identify and evaluate potential risks and quality issues in collaboration with project team leadership and other relevant parties (e.g., Project Management Quality Management, operational and functional staff). Together with these parties, determine appropriate mitigation measures.• Collaborate with other PQLs assigned to the client to identify quality trends, program-wide corrective and preventive actions and share lessons learned• Serve as quality consultant to senior project leadership personnel assigned to strategic or key accounts and assist with the oversight of quality aspects of the client program• Review key portfolio documentation from a quality standpoint• Provide support and consultancy for portfolio quality issues• Facilitate portfolio level compliance with the Corrective and Preventive Actions (CAPA)• Coordinate Project Quality Leads assigned to the client as needed• 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 required.• Oversee the collection and reporting of portfolio quality metrics. Evaluate the quality status of a portfolio by reviewing applicable quality metrics.

Qualifications

Excellent interpersonal, verbal and written communication skills. Client focused approach to work. Substantial clinical trials experience. Leadership and/or project management skills and experience. 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%.
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

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