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Job Description

Objective / Purpose: Describe at the highest level the team where this job sits and how this role will contribute to the team’s delivery of critical function.

Provides quality assurance oversight of the global and local 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. Defines and implements a risk-based program audit strategy, ensuring the communication of significant quality and compliance risks to key stakeholders and Management, and ensuring appropriate and timely investigations and mitigations are in placeLeads the inspection readiness programs, the management of the inspection, and the response and follow-up activities. Ensures that inspection risks are well-communicated and mitigated for both sponsor and investigator site inspections.

Accountabilities: Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified.     

Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned development program teams and leadershipAssume complex assignments on issues or studies where there is no precedentMentor and provide support to Manager level CPQ personnel, as neededDevelop 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 the 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 proceduresLead or assist with investigations into significant quality issues, scientific misconduct, and serious breaches 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 and timely inspection responses and follow-up actionsAnalyze, report, and present metrics for assigned programs to development teams R&D, and Quality management; recommend any required actions and monitor implementationCollaborate with Clinical Safety Quality Compliance team to identify and mitigate GCP quality and compliance issues with potential impact across multiple programs, Takeda sites, or functional groups.  Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolutionParticipate in due diligence activities and process improvement initiatives as requested by management

Education & Competencies (Technical and Behavioral): List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.
 

BA/BS degree required; advanced degree preferred.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.Recent experience in leading and hosting India Central Drugs Standard Control Organization (CDSCO) inspection and other health authority inspection experience with FDA, MHRA etc.Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical developmentAdvanced knowledge in the conduct and reporting of audits and the translation of findings into corrective action plans that mitigate risks to the company, patient safety and data integrity.Collaborative team player proficient in stakeholder management, possessing a positive attitude, critical thinking skills, and the ability to swiftly identify creative solutions to complex problemsStrong technical writing skills; able to write quality positions, audit reports, and procedures.Excellent communication skills with ability to negotiate and influence without authority in a matrix environmentStrong judgment, project management, and decision-making skills; able to manage multiple projects and demanding timelinesSuperior attention to detail and ability to analyze complex dataAble to travel to various meetings, inspections and/or audits, including overnight trips and international travel.

LocationsIND - Bengaluru

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time