Senior Project Quality & Risk Lead

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.