Job Description

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 forassisting 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.
You will also:
• 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 teamsQualifications

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%

Education:

Bachelor's Degree or other relevant experience required. Life-science or other health-related discipline preferred.

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.