Senior Manager, Clinical Program Quality and Excellence; Oncology

• 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 qualityexpertiseand risk-based advice.

• With theguidanceof 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 andappropriateandtimelyinvestigations 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.

• ProvideexpertiseinGCP compliance interpretation, consultation, training, and recommendations to assigned program teamsandleadership

• Develop and implementprogram-specific risk-based audit and compliance strategy andmanageaudits of sites,clinical trial delivery,documents, databases,vendorsor internal systems in compliance withGCPand Takeda policies and procedures.
  
  Audits require advanced auditing skills and may involve technically complex assignments.

• Assess impact of audit findings and other identified compliance risks tosubject safety, data integrity, and business operations and escalation compliance risks to CPMQ management.

• Ensureauditreports and corrective actions are developed and completed within timelines mandated in internal procedures

• Facilitateinvestigations intosignificant quality issues,scientificmisconductand serious breach of GCP;facilitateidentification ofroot causeand development of appropriate corrective and preventive actions;track actions and confirm effectiveness;ensure reporting of potential or confirmed violations to regulatory authorities.

• Assist with management ofGCPhealth authorityinspections;lead clinical development teams in preparation for announced inspections and provide GCPcompliance technical support during inspections of investigator sites and Takeda.
  
  Facilitateappropriateandtimelyinspectionresponsesandfollow-up actions.

• Collaborate with
  
  Quality
  
  Compliance and Systemsteamtoidentifyand mitigate GCP quality and compliance issues with potential impact across multiple compounds,Takedasites, or functional groups.

• Analyse,report, and presentmetrics for assignedprogramstodevelopment teams and CPMQmanagement;recommend any required actions and monitor implementation.

• Escalatesystemicand/or criticalproblemsand recommend appropriate solutionstoseniormanagement for immediate and long-term resolution

• PerformadditionalGCPrelatedactivitiesuponrequest by CPMQ management

• BS/BArequired;
  Advanced Degree preferred.

• Minimumof 7yearsofexperience in the pharmaceutical,biotechnologyor related health care industry.

• Minimum5 years of GCP-related Quality Assuranceor relevant clinical trialexperience.

• Extensive knowledge and/or awareness ofICH GCP R2andapplicable globalregulationsand guidance for clinical development

• Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.

• Collaborative team player with a positive attitude and ability to think and act quickly toidentifycreative solutions to complex problems

• Effectivetechnical writing skills; able to write quality positions, audit reports, and procedures.

• Excellent communication skills with ability to negotiate and influencewithout authority in a matrix environment

• Strong judgment, projectmanagementand decision-making skills; able to manage multiple projects and demanding timelines

• Superiorattention to detail and ability to analyse complex data

• GCP Quality Assurance registration/certification preferred

• Routine demands of an office-based environment

• Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.

• Requires approximately 30% travel.

We…