Clinical Program Quality Lead

At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

You will lead the Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including the management of audits, quality issues and investigations, and inspections.

This is a remote role that reports to the Head of Neuroscience, Clinical Quality Assurance.

Roles and Responsibilities 

• Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned high priority development program teams.
• Assume complex assignments on issues or studies where there is no precedent
• Mentor and provide support to Manager level CQA personnel.
• Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures. Audits require advanced auditing skills and involve technically complex assignments. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CQA management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures.
• Lead investigations into quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
• Lead GCP health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Takeda. Facilitate appropriate inspection responses and follow-up actions.
• Analyze, report, and present metrics for assigned programs to development teams R&D, and Quality management; recommend any required actions and monitor implementation.
• Collaborate with Quality Compliance and Systems team to identify and mitigate GCP quality and compliance issues with potential impact across multiple programs, Takeda sites, or functional groups.
• Escalate systemic and critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution.
• Participate in due diligence activities and process improvement initiatives as requested by management, and may act as supervisor for temporary contractors.
• Provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues and recommend mitigations.
• Liaise with various Takeda R&D functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance.
• Independently manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations. Audits conducted require advanced auditing skills and may involve technically complex assignments, including audits of high-risk studies/vendors.

Qualifications and Experience

• BA/BS degree required.
• Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
• Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial experience.
• Knowledge and awareness of ICH GCP and applicable global regulations and guidance for clinical development.