Project Quality and Risk Manager

Due to a growing portfolio, we are currently looking for an experienced Project Quality and Risk Manager

This role could be either office or home based in any of the following locations: Lithuania, Romania, Serbia, Poland, Hungary, Italy, Croatia, Spain. The offices for given locations are all open planned, and you will be working in an innovative and collaborative environment with your international peers and colleagues. 

The Project Quality and Risk Manager may be assigned as Global Project Quality and Risk Lead (PQRL)/Portfolio Quality Lead (PFQL) for large sized projects with complex challenging indications and/or involving multiple countries/regions, and/or for key customer accounts. As Global PQRL/PFQL, this role is expected to coordinate work with other regional PFQL/PQRLs. The Project Quality and Risk Manager is also required to contribute to management in developing work process optimization and provides operational leadership through mentoring new/junior members of the team.

The Project Quality and Risk Manager, when assigned as Project Quality and Risk Lead, assumes the lead of Quality oversight responsibility and has overall accountability for the execution of the Project Quality Life Cycle Plan (PQLC) within the projects. 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.

The Project Quality and Risk Manager is acting 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. The Project Quality and Risk Manager assigned to projects and/or accounts will collaborate closely with the broader PQRM groups and other quality teams.

Skills:

• Excellent communication skills, including verbal and written communication, active listening, providing constructive feedback, and facilitating group discussions.
• Strong interpersonal skills, able to develop relationships and partnerships, build rapport, persuade and influence teams, motivate others, manage performance, and develop talent.
• Expert project manager with strong organizational and planning skills, and competency in risk management with thoughtful action planning.
• Personal awareness and emotionally intelligent, ability to self-motivate, innovate, delegate, and manage time as well as taking ownership and accountability for deliverables.
• Robust Skills in interpreting, synthesizing, inferring, evaluating, and extracting pertinent data to identify areas of risk, trends, and aggregated issues.
• Highly Adaptable to changing environments, able to think quickly, able to deal with ambiguity, and learn new tasks applying routine knowledge.
• Quality-oriented with an attention to detail, taking initiative, ownership, and accountability for deliverables.
• Expertise to manage the complexity of a matrix environment while valuing the importance of teamwork.
• Ability to travel 10%- 15%

Knowledge and Experience:

• Demonstrated experience in Quality or Risk Management activities
• Expertise in root cause methodologies (e.g. 5-whys, fishbone diagram, etc.) and CAPA development
• Expertise in Clinical Trial Risk Management
• 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.