Associate Director, Clinical Program Quality Investigations

Role Summary

Associate Director, Clinical Program Quality Investigations is responsible for ensuring the compliance of deviation management and serious breach process. This role focuses on defining activities, processes, and standards to meet quality requirements relevant to deviation management and serious breach. This position supports Takeda's mission by maintaining high standards of quality and compliance in clinical trials.

Responsibilities

• Drive the implementation of clinical deviation management and Serious Breach process across Clinical Program Quality.
• Acts as Subject Matter Expert (SME) for clinical deviation management, and Serious Breaches investigation and reporting to regulatory agencies.
• Act as strategic partner to Clinical Program Quality for complex clinical deviations and Serious Breaches.
• Review the clinical deviations across studies managed by Clinical Program Quality team and share insights to trends to Clinical Pharmacovigilance and Medical Quality and R&D Quality leadership for proactive risk mitigation and actions.
• Escalates quality issue trends to R&D Quality Leadership and R&D leadership.
• Ensure compliance to Deviation management and Serious Breach procedures by providing expert advice on the process to Clinical Program Quality.
• Ensure Serious Breach are adequately assessed and reported within the timelines.
• Lead the Clinical Program Quality, Deviation Management and Serious Breach review board meetings.
• Lead complex quality investigations impacting the clinical trial delivery systems.
• Provide Quality Leadership for Serious Breach quality investigations ensuring the right stakeholders are engaged in impact assessment, root cause analysis and CAPA development.
• Oversee the Serious Breach Reporting Service and ensure that the service is executed as planned, including regular reconciliation of information.
• Provide data insights to Clinical Deviations and Serious Breaches to identify systematic quality and compliance risks, and proactively provides strategic and tactical directions in the mitigation.
• Actively participate and contribute to the design, implementation and advancement of the Clinical Program Quality strategy, model, and operations as a key member of Clinical Quality program leadership team.

Qualifications

• BSc in a scientific or allied health/medical field (or equivalent degree).
• Minimum of 7 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 3 years of experience in GCP Quality/Compliance.
• Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.
• Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, deviation management, Serious Breaches, investigations and remediation activities on a global level.
• Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.
• Skilled in managing global, cross-functional projects.
• Successful management of business transformation/change management initiatives e.g. quality system integration, outsourcing strategy etc
• Excellent communication skills to convey message. Exceptional active listening skills to understand the needs and concerns of others, which is crucial for finding win-win solutions.
• Outstanding ability to apply critical thinking and problem-solving abilities to address challenges and advocate for solutions.
• Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.

Skills

• Quality management
• Regulatory compliance (GCP/GVP)
• Deviation management and Serious Breaches
• Investigation and root cause analysis
• CAPA development
• Data analytics and risk assessment
• Cross-functional leadership

Education

• Bachelor‚Äôs degree in science or allied health/medical field (or equivalent)

Additional Requirements

• Location: Cambridge, MA (Hybrid)