Location: Barcelona, Spain
Job reference: R-204854
Date posted: 08/28/2024
As part of the Development Quality Team, you will drive Quality Culture with Development, Regulatory and Safety stakeholders, through learning, embedding a quality mindset, and executing on continuous improvement opportunities. You will be responsible for managing business relationships with defined clinical development stakeholder groups and senior leaders in Development, Regulatory and Safety and for the strategic development and delivery of a GCP risk based robust quality management activities for these stakeholders. The Director will mentor junior team members as well as provide guidance when dealing with high risk complex GCP issues. The Director will lead departmental process improvements and support cross functional process improvements.
You will be responsible for: Development and execution of the overarching strategy related to proactive and sustainable quality and compliance for assigned areas. Where applicable, represent DQA on Alexion Global Program Teams (GPTs) and Regulatory Strategy Teams (RSTs) to proactively identify critical to quality risks and mitigation strategy to drive excellence in study design and execution and to minimize risk to regulatory submission/approval. Proactively identify Key Quality and Risk Indicators (KQIs/KRIs) for assigned areas and develops mechanisms of KQI/KRI, detection, oversight and trending with relevant stakeholders. Work with Development Quality peers to ensure escalation of risks and issues identified at a study level to relevant stakeholders. As required, provide guidance to junior team members for global/systemic clinical quality issue investigations. Mentor new and existing employees as per established on-boarding plan and on focus improvement areas. Work with cross functional and other quality partners to proactively identify areas of risk, improvement, or KPI/KQIs, as applicable. Serve as the quality expert for global/systemic clinical quality issue investigations, which includes:
In collaboration with issue owners lead Quality Event reportability assessments, investigations and Root Cause Analysis. Perform Quality Event risk assessments and trending (deviations, audit findings, inspection findings etc.) to determine robust CAPAs. Acts as quality approver for Quality Issues and CAPAs as assigned. Be accountable for leading inspection readiness as assigned including but not limited to:
Provide leadership and guidance to team members in promoting a culture of inspection readiness and sustainable clinical compliance. Provide guidance to team members in Inspection Readiness and Preparation Activities (e.g., SME training, Mock inspection etc.). Support follow up and tracking of inspection commitment and effectiveness checks. Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization and quality governance requirements where applicable. Participate in and compile data for quality management reviews, risk reviews, and other study/TA/Asset level quality reviews. Drive continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issues. Actively participate in meetings driving quality and business performance. Support Due Diligence and integration activities as assigned. Lead Sponsor Inspections and Drive CAPA development. You will need to have: Bachelor's degree in life science, or equivalent field, required. Minimum of 12 years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and compliance. Established knowledge of GCP regulations and guidelines (EMA, FDA, PMDA etc.). Significant experience with GCP investigations, risk assessments and CAPA management. Extensive experience in Project Management and leading cross functional initiatives. Experience participating in GCP regulatory inspections. Experience with multinational products and regulations as well as with mandated risk management plans. Experience in training and coaching people. Ability to travel up to 10%. The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: Advanced degree preferred. Gene Therapy expertise. Phase 1 expertise. Competencies to be successful for this position include: Quality, process, and compliance oriented. Strong interpersonal skills. Critical thinking. Integrity. Communication. Teamwork. Problem solving. Risk-based approach mindset. Stakeholder management including senior LT.
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