Clinical Program Quality, Associate Director, R&D, China
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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Job Description
roles& responsibility :
- 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.
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.
Locations
Shanghai ChinaWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeRequired Experience:
Director
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
