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

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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.
• Develops and executes strategic activities to ensure that outsourced non-clinical Research study activities (e.g. GLP non-GLP submission-relevant) are compliant with applicable regulations and Takeda requirements.
• Provides focused leadership in the development implementation and administration of supplier quality oversight activities and processes for externalized non-clinical studies.

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
• Provide functional leadership and direction on applicable regulations guidance documents and Takeda requirements (e.g. GLP OECD data integrity) to stakeholders to proactively address risks resolve issues and ensure compliance of Research programs non-clinical studies and submission-relevant activities.
• Identify direct and execute quality initiatives across various internal and external groups (stakeholders and third parties) to maintain quality compliance and consistency across programs and projects in Research.
• Lead qualification and compliance assessments (either by direct audit participation or via management of contract auditors) of external service providers conducting non-clinical studies and other related Research activities.
• 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

Education & Competencies (Technical and Behavioral):

• 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

• Comprehensive knowledge and understanding of domestic and international GLP regulations related regulations and guidance documents.
• In-depth knowledge of the drug development process non-clinical operations and regulatory compliance with the ability to interpret requirements anticipate issues make informed decisions and respond rapidly to emerging quality situations.
• 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.