Project Quality & Risk Lead II応募 求人ID 65715BR ロケーション ポーランド共和国 仕事内容
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.
This role can be home based anywhere in Poland or office based in Warsaw. The office is open planned, and you will be working in an innovative and collaborative environment.
We are recruiting for a Project Quality & Risk Lead II who will be responsible for assisting with preparations, conducting and responding to/actioning plan development for audits/inspections as assigned. This role will partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. As well as providing quality expertise through the execution of quality SOPs to support operations, leadership and clients. With support of your line manager or Senior PQRL, you will 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.
• 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
• 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
Skills & Experience
- 5+ years’ experience in late phase clinical research.
- Experience using root cause methodologies (5-whys, fishbone diagram, etc.)
- Knowledge of ICH-GCP principles
- English proficiency (written and oral)
- Good 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%
- Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred.