Clinical Quality Project Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

You will be partnering with a well-known global pharmaceutical company with a strong portfolio inmultiple therapeutic areas.

You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you if you are looking for an environment where people feel they belong and are empowered to reach their full potential, perform at their best and make a valued contribution to saving lives.

• Drives Operational Excellence within RDQRM as Business Process Consultant (BPC) by providing consultancy on process elaborations/updates/improvements in close collaboration with the respective Business Process Owner (BPO)
• Provides leadership and guidance on Quality Document (QD) & Controlled Document (CD) management activities (e.g., support QD authors during writing process, oversee QD/CD lifecycle management within department in close collaboration with R&D SOP Management)
• Participates in the DEC (Development Excellence Council) as back-up DEC representative for RDQRM, and oversees and manages respective DEC tasks within RDQRM (e.g., manage DEC elaboration & review requests)
• Acts as back-up TAR (Training Assignment Responsible) for RDQRM, i.e., oversees and manages Training assignments in close collaboration with the RDQRM leaders
• Collaborates with RDQRM Leaders as well as BPOs for all related DEC and TAR tasks
• Coordinates stakeholders from various parts of the R&D organization

#LI-MC6

• Minimum 8 years QA experience or relevant experience in international pharmaceutical and/or biotech industry, in particular medical quality management, clinical development, or regular compliance
• In depth knowledge of applicable worldwide regulations and ICH guidelines
• Proven GCP (and GVP) expertise, basic knowledge in other GxP areas a plus (i.e., GLP, GRP, GMP)
• Experienced in Controlled Document management (i.e., writing, reviewing, process modelling)
• Broad knowledge/expertise in continuous improvement with background in appropriate tools/procedure, e.g., strong quality orientation and understanding of metrics; Lean Six Sigma training a plus; demonstrated knowledge of Root Cause Analysis techniques.
• Solid working knowledge of principles and concepts of risk-based Quality Assurance
• Broad understanding of the drug development process and its regulatory environment