Associate Director, Development Asset Quality (DAQ) Location: Barcelona
This is what you will do: 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 stakeholder groups and senior leaders in Development, Regulatory, and Safety and for the strategic development and delivery of GCP risk-based robust quality management activities for these stakeholders.
You will be responsible for managing the Associate Directors/study quality leads including, but not limited to, providing mentoring and coaching.
You will be responsible for: Assisting in the development of an overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio for assigned Therapeutic Area(s) (TAs). Where applicable, represent DAQ on Alexion Global Program Teams (GPTs) and Regulatory Strategy Teams (RSTs) to proactively identify critical to quality risks and mitigation strategies to drive excellence in study execution and to minimize risk to regulatory submission/approval. Work with cross-functional and other quality partners to proactively identify study level Key Quality and Risk Indicators (KQIs/KRIs) and develop mechanisms for KQI/KRI detection, oversight, and trending with Clinical Development and Ops stakeholders and other functions such as Risk-based Quality Management. Serve as the quality expert for global/systemic clinical quality issue investigations, which includes leading Quality Event reportability assessments, investigations, and Root Cause Analysis in collaboration with issue owners. Perform Quality Event risk assessments and trending (deviations, audit findings, inspection findings, etc.) to determine robust CAPAs. Act as quality approver for Quality Issues and CAPAs as assigned. Lead inspection readiness for assigned programs/portfolio including providing 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 commitments and effectiveness checks for assigned programs/Therapeutic Area. Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization and quality governance requirements where applicable (e.g., TMF health oversight, CRO/Vendor oversight, medical device requirements, etc.). 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. You will need to have: Bachelor's degree in life science, or equivalent field, required. Minimum of 8+ 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 GxP/GCP regulations and guidelines (EMA, FDA, PMDA, etc.). Significant experience with GxP investigations, risk assessments, and CAPA management. Experience participating in regulatory inspections. Functional planning experience and ability to develop functional vision, priorities, and tactics. Experience with multinational products and regulations as well as with mandated risk management plans. 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 accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours.
We would prefer for you to have: Advanced degree preferred. Competencies to be successful for this position include: Quality, process, and compliance oriented. Strong interpersonal skills. Critical thinking. Integrity. Communication. Teamwork. Problem solving.
#J-18808-Ljbffr
