Manager, Clinical Program Quality

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

OBJECTIVES:

• Provides quality assurance oversight of the global clinical research programs in Research and Development (R&D), Plasma Derived Therapy (PDT), Vaccines Business Unit (VBU), Oncology Business Unit (OBU) and Global Medical Marketed Products Development (MPD) with the overall goal of inspection readiness.
• Serves as a Strategic Quality Thought Partner to Clinical Program Teams and other key stakeholders in the delivery of the clinical research programs, providing professional clinical research quality expertise and risk-based advice. 
• With the guidance of Head of Clinical Program Quality, TAU, defines and implements a risk-based program audit strategy, ensuring communication of significant quality and compliance risks to key stakeholders and Management and appropriate and timely investigations and mitigations are in place.
• Leads the clinical pre-approval inspection (PAI) readiness programs, the management of the inspection and the response and follow-up activities. Ensures that any inspection risks are well-communicated and mitigated. These inspections include both sponsor and investigator sites.

ACCOUNTABILITIES:

• Under supervision, provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned program teams and leadership
• Under supervision, develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, clinical trial delivery, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures. 
• Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CPMQ management.  Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
• Assist with investigations into significant 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.
• Provide GCP compliance support during inspections of investigator sites and Takeda. Assist with development of appropriate and timely inspection responses and follow-up actions
• Collaborate with Quality Compliance and Systems team to identify and mitigate GCP quality and compliance issues with potential impact across multiple compounds, Takeda sites, or functional groups.  
• Analyse, report, and present metrics for assigned programs to development teams and CPMQ management; recommend any required actions and monitor implementation.
• Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
• Perform additional GCP related activities upon request by CPMQ management

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BS/BA degree required; advanced degree preferred.
• Minimum of 5 years of experience in the pharmaceutical, biotechnology or related health care industry.
• Minimum 2 years of GCP-related Quality Assurance or relevant clinical trial experience.
• Knowledge and/or awareness of ICH GCP R2 and applicable global regulations and guidance for clinical development
• Knowledge of conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safet