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Senior Project Quality & Risk Lead
Parexel International Corporation
Lithuania - Any Region - Home Based
We are recruiting for a homebased Senior Project Quality & Risk Lead in Lithuania to analyze key risk indicators and investigate risk signals by performing, reporting and coordinating risk-based quality evaluations for assigned projects using dashboards, reports, metrics and other available tools.
You will also be responsible for:
•Facilitate identification, investigation and remediation of quality issues as assigned using available tools and methodologies. Provide oversight, transparency and tracking of quality issues for assigned studies.
• Provide expert quality advice as assigned, responding to consultancy requests and requests for SOP deviations using ICH-GCP
• Develop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the roles of Portfolio/Client Quality Lead.
• Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requested.
• Mentor PQRLs as needed.
• Serve as an integration partner to facilitate induction to PQRM.
QualificationsSkills:
• Excellent interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback.
• Analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions.
• Ability to develop professional, collaborative relationships both internally and with the client.
• Skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues.
• Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge.
• Ability to plan, organize, prioritize and manage workload independently, keeping the patient and client at the focus.
• Quality oriented with an attention to detail, taking initiative, ownership and accountability for deliverables.
• Ability to manage the complexity of a matrix environment while valuing the importance of teamwork.
• Ability to travel 30%-50%
Knowledge and Experience:
• 5-8 years’ experience in late phase clinical research
• Expertise in root cause methodologies (5-whys, fishbone diagram, etc.) and CAPA development
• Expertise with ICH-GCP principles
• English proficiency (written and oral)
Education:
• Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred.
• Master’s Degree in a science, technology or industry-related disciple preferred.
Job posted: 2020-09-23