Senior Project Quality and Risk Lead

We are currently looking for experienced Project Quality and Risk Lead​s with expertise with ICH-GxP principles and clinical trial regulations to be based in Poland or Lithuania or Romania or Hungary.

As the Senior Project Quality and Risk Lead you will actively act as Risk Manager, being responsible to coordinate Critical to Quality (CtQ) identification, risk identification, evaluation, and controls.

This position can also be part of a global project management team.
Senior Project Quality and Risk Lead assigned to projects and/or accounts will collaborate closely with the broader PQRM groups and other quality teams.

The PQLC model delivers the services of PQRLs who provide expert quality advice to the project team regarding potential risks and the oversight of the risks through-out the lifecycle of the clinical trial.
Partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise to support operations, leadership, and clients, enabling the safeguarding and maintenance of patient safety, data integrity and regulatory compliance.

Skills:

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

- Superior analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming, and imagining alternatives and assessing the effectiveness of actions.

- High ability to develop professional, collaborative relationships both internally and with the client.

- Very good skills 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.

- Highly quality oriented with an attention to detail, taking initiative, ownership, and accountability for deliverables.

- Advanced ability to manage the complexity of a matrix environment while valuing the importance of teamwork.

- Ability to travel 10% - 15%.

Knowledge and Experience:

- Advanced level experience and understanding in any area or combination of either Phase II-III or Late Phase /IV clinical project management and demonstrable experience in Quality or Risk Management activities are essential.

- Expertise with ICH-GCP principles

- Expertise in root cause methodologies (5-whys, fishbone diagram, etc.) and CAPA development

- Previous CRO experience is strongly preferred (applications from candidates with pharma experience will also be considered)

- English proficiency (written and oral)

Education:

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