Associate Director, Clinical Quality Compliance

Job Title : Associate Director, Clinical Quality Compliance

Location : Cambridge, MA

About the role:

As the Associate Director, Clinical Quality Compliance, you will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management. You will maintain a state of control by implementing monitoring and control systems that ensures the quality systems supporting the clinical trial delivery is and aligned with applicable regulations. You will report to and act as a strategic expert to the Head of GCP Quality Compliance in developing GCP Compliance strategies, in managing the operational activities of and building capabilities within the GCP Compliance function and in ensuring agreement on the CPMQ vision.

How You Will Contribute:

• Partner with the different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting investigations and developing adequate corrective and preventive actions (CAPAs), managing changes and facilitating improvement that is in consideration of Takeda's values and priorities.
• Lead the clinical trial delivery system inspection readiness program, including the implementation of a strategy. Engage with relevant responsibilities and partners to ensure inspection readiness, driving accountability and transparency. Function include Global Development Office, Data Science Institute, Global Regulatory Affairs, Procurement, Legal.
• Provide insights to latest requirements, operational and compliance metrics and storyboards, identify quality and compliance inspection risks, and provide tactical directions in the mitigation.
• Host GCP inspections, and provides strategic direction to relevant responsibilities and Subject Matter Experts (SME).
• Ensure a communication plan is in place, that enables knowledge sharing of insights and risks. Communicate the progress of inspections daily, summarizing the inspection activities and potential observations and mitigation activities. And timely escalates to management.
• Lead the inspection response activities, ensuring the responses are adequate, reviewed and approved internally by the relevant partners, at the right levels and submitted on time. Provide input to response to ensure the impact is thoroughly assessed, appropriate cause is identified, and, measurable, achievable, time-bound CAPAs are developed.
• Oversee the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late. Mitigates and escalates any risks. Ensure appropriate effectiveness checks are developed for relevant inspection CAPAs. Provide input to the effectiveness check plans, and reviews and approve outcome.
• Be a Subject Matter Expert (SME) on the Clinical Quality Compliance activities including deviation management, quality investigation, corrective and preventive actions (CAPA) management and oversight and change control. Represent Clinical Quality Compliance in these topics in inspections.
• Support and provide relevant guidance to other non-GCP specific inspections (e.g., GVP, GMP).
• Lead complex quality investigations improving the clinical trial delivery systems. Provide Quality Leadership for other quality investigations ensuring the right partners are engaged in impact assessment, root cause analysis and CAPA development.
• Develop lessons learned from on regulatory inspections, and quality investigations. Promote knowledge management.
• Lead improvements projects that ensure a compliant quality systems in the clinical trial delivery quality systems.
• Approve controlled procedures related to clinical trial delivery quality systems to ensure regulatory and past inspection commitments are considered.
• Escalates issues of potentially critical non-compliance and lack of urgency in remediation to senior management. Analyze results, quality issues and investigation to identify applicable trends and to promote a state of compliance.
• Develop and monitor relevant metrics and Main Performance/Quality Indicators (KPI/KQI). Mitigates, communicates, and escalates any risks flagged by the metrics/KQIs, ensuring actions are commensurate to the risk and timely. Drive the development and execute the strategy to understand the health of the clinical trial delivery quality system (i.e. risk register, KPIs).
• Contribute to any relevant quality and compliance governance in Takeda, including the and the Clinical & Safety Quality Council, communicating any quality or compliance risks and opportunities, continual improvements and successes.

What you bring to Takeda:

• BSc in a scientific or allied health/medical field (or equivalent degree).
• Minimum of 10 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 5 years of experience in GCP Quality/Compliance.
• Experience with pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.
• Experience must include successful implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections and remediation activities on a global level.
• Experience managing complex organizational compliance issues and in implementing organization-wide compliance projects.