Project Quality & Risk Lead I

We are recruiting for 2 x Project Quality & Risk Lead 1 in Lithuania we have 1 homebased role and 1 office based role. You will be responsible for assisting with preparations, conduct and response/action plan development for audits/inspections as assigned.

You will be responsible for:

• Enable audit/inspection preparation including helping team set priorities and reviewing key documents

• Provide onsite or remote support as needed

• Track all audits/inspections and reports’ status

• Lead project team to investigate root causes

• Facilitate development of robust CAPA

• Review all audit/inspection responses prior to final QA review if necessary

With support of LM or experienced PQRL, provide expert quality advice as assigned, responding to consultancy requests and requests for SOP deviations using ICH-GCP, Parexel processes, regulatory requirements, applicable country requirements and input of appropriate subject-matter-experts.

• Provide real-time quality expertise to enable project teams to deliver first-time quality

• Consult SMEs including other quality experts when necessary to resolve

• Review and investigate possible project-level SOP deviations as requested by project teams

Qualifications

• Good interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback.

• Developing 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.

• Developing 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 with LM guidance, 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:

• 2-5 years’ experience in late phase clinical research

• Knowledge of 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.