Clinical Program Quality, Associate Director, R&D, China

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Job Description

Objective / Purpose:

• 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 place
• Leads 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:

• Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned development program teams and leadership
• Assume complex assignments on issues or studies where there is no precedent
• Mentor and provide support to Manager level CPQ personnel, as needed
• 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 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 procedures
• Lead 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 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 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 resolution
• Participate in due diligence activities and process improvement initiatives as requested by management

R&D Qualifications & Skills 

• 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 NMPA/CFDI 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 development

• Advanced 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 problems
• Strong 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

environment

• Strong judgment, project management, and decision-making skills; able to manage multiple projects

and demanding timelines

• Superior attention to detail and ability to analyze complex data
• Able to read Chinese and speak Mandarin fluently
• Able to travel to various meetings, inspections and/or audits, including overnight trips and international travel.

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