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Associate Director, Clinical Quality Performance |
hace 2 meses
(J-031) Associate Director, Clinical Quality PerformanceBarcelona, CataloniaHeadquartered in Mississauga, Ontario, AstraZeneca has been recognized as a Greater Toronto Area Top Employer for eight straight years. We pride ourselves on creating a collaborative culture that champions knowledge-sharing, ambitious thinking, and innovation - ultimately providing employees with the opportunity to work across teams, functions, and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.Our commitment to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work.Our PositionReporting to the Senior Director, Clinical Quality Performance (CQP), the Senior Quality Lead supports the delivery of Quality Management activities related to clinical development within RD, working across the business to embed quality/compliant practices while leading and guiding proactive inspection readiness activities within Development Operations and other Clinical RD functions.Accountabilities/ResponsibilitiesEstablish and maintain effective systems and processes to support key performance areas for Clinical Quality Compliance (CQC) to maintain Quality Management excellence.Collaborate effectively with colleagues to support initiatives/activities and act as a quality champion advocating a culture of quality across RD.Provide advice and standard process 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, empower clinical colleagues to conduct root cause analysis and define CAPA plans and effectiveness check plans.Assist functional partners with CAPA effectiveness checks.Assist functional representatives as they prepare for regulatory inspections (where necessary).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 management.Assist with CQC communications and issue resolution.Assist with identifying and implementing continuous improvements by reporting new insights of quality-related trends and metrics, highlighting areas of need where necessary, and tracking related activities.Actively participate in internal and external quality groups/operational committees, sharing relevant information, experience/knowledge, focused on improving the way of working.Support CQC Leadership in the strategic direction and priorities of the group.#J-18808-Ljbffr
