.Location: Barcelona, Spain (On-site): We requiere 3 days working from the office and 2 days working from home.Join us as an Associate Director, Clinical Systems Quality and be part of our dynamic Biopharmaceuticals R&D team. In this role, you will support the delivery of Quality Management activities related to clinical development within R&D. You will work closely with collaborators across the business to embed quality/compliant practices while leading and guiding proactive inspection readiness activities within Clinical Operations and other Clinical R&D functions.Typical Accountabilities:Establish and maintain effective systems and processes to support key performance areas for CQC to maintain Quality Management excellenceCollaborate effectively with colleagues and stakeholders to support quality and compliance related initiatives/activities and act as a quality champion advocating a culture of quality across R&D.Provide advice and standard methodology guidance on GCP or other relevant regulatory standards (such as GCP for labs, GAMP, 21 CFR Part 11, etc.) for quality events, initiatives and improvement programs (issues/audits/inspections/ corrective/preventive actions [CAPA] and new/current business processes).Where necessary, provide support to stakeholders to ensure appropriate root cause analysis is conducted and CAPA plans (and in some cases, effectiveness check plans) are defined. Assist functional partners with CAPA effectiveness checks.Assist functional representatives as they prepare for regulatory inspections (where vital)Coordination of defined GCP systems audits and advising where necessary on other audit outcomes (responses, CAPAs, lessons learned)Support identification and management of quality risks, including mitigation of risks and communication of significant risks to managementAssist with CQC communications and critical issuesAssist with identifying and implementing continuous improvements by collating including reporting quality related trends and metrics periodically, increasing where vital, and tracking related activities.Participate in any assigned operational committees and provide clinical quality expertise to external partnersActively participate in internal and external quality groups and fora sharing relevant information, experience/knowledge and best practices.Support CQC Leadership in the strategic direction and priorities of the group. Supply to CQC objectives and strategies that drive a culture of quality.Maintain current knowledge and awareness of regulations / guidance as well as any internal processes pertaining to clinical trials; provide interpretationsof regulations and assessing impact on our systems and providing recommendations, where necessary.Provide quality and compliance support to assigned functional areas within Clinical Operations and R&D pertaining to the above
