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

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工作描述

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.

R&D Qualifications & Skills

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.

地点

中国上海中国北京

员工类型

员工

员工子类型

正式

时间类型

全职