Global Clinical QA Manager
3 days ago
Company Description
As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of "Happiness with Vision" by providing valuable products and services to patients, consumers, and medical professionals around the organization.
Since its establishment in Japan in 1890, and guided by its CORE PRINCIPLE, "Tenki ni sanyo suru," Santen has been committed to helping people maintain and improve their eye health, and is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people worldwide.
Our duty is to create a future in which as many patients and consumers as possible can lead happy and fulfilling lives. We will continue to contribute to the realization of better eye care by providing solutions that eliminate bottlenecks in the diagnosis and treatment of eye diseases, thereby revolutionizing the treatment flow. Each of us is deeply committed to challenging ourselves, building an organization that brings together diverse internal talents and external expertise, and to doing our utmost to realize a society in which people everywhere can feel happy through vision-related experiences. Isn't it exactly the kind of environment you want to belong in?
Job Description
Mission
In this role, you will provide direct support to the Head of Global Clinical Quality (CQA) and Pharmacovigilance Quality Assurance in managing compliance related to cGCP, pharmacovigilance, and other related activities. The individual will provide compliance support to Clinical Development (Clinical Operations, Data Management, Biometrics Data Science, Safety/PV), overseeing the GCP audit programs and developing, maintaining, and continuously improving the GCP Quality System. Participate in internal audits and global regulatory inspections, including FDA/EMA. As a subject matter expert for specific Good Clinical Practices. Through the execution of these operations, you will ensure compliance with GCP and other relevant regulations, contributing to the realization of "Happiness with Vision" for people around the world.
Essential Duties And Responsibilities
- Support continuous improvement of quality processes and systems that ensure compliance with clinical study-related activities in collaboration with contract research organizations and in-house clinical development.
- Design Clinical QA folders for all development studies that are easy to navigate and identify. Locate current and archive files from the Quality documentation system (VQD-Veeva vault) and file them into a new filing system. Maintained Clinical Quality documentation.
- Support preparations for and follow-up of effective audits of investigator sites, essential documents (Protocol, IB, Master Template Inform Consent, CSR), Trial Master Files, vendors, and internal processes.
- Provide effective oversight of systems cross-functionally in clinical research and development in collaboration with matrix team members (attend internal Study Team Meetings and corresponding external study meetings).
- Ability to identify, evaluate, and communicate risks to Clinical Quality Assurance processes and/or systems with recommendations for resolution.
- Support training staff and external partners in compliance, current clinical practices, and procedures.
- Maintained annual Internal audit schedule and external Audit Schedule in the Annual audit plan. Manages corresponding workflows and ensures documentation is maintained per procedures. Assist in vendor audits and CAPA follow-ups and closure.
- Promote collaboration internally and with external partners to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines.
- Support GCP inspection readiness & Provide in-house GCP training.
- Travel required 25-30 %.
Qualifications
- 6+ years of experience in Clinical Quality Assurance, Quality Assurance, or Clinical Operations within Pharma or Biotechnology industry. Experience with all phases of clinical trials.
- Broad knowledge of risk-based quality systems consistent with Good Clinical Practice. Ability to identify and resolve quality issues.
- Attention to detail as well as crisp, clear and concise style in written and oral communications.
- Demonstrated ability to work independently and flexibly in a fast-paced, high-growth environment.
- Bachelor's degree in a scientific field.
- Fluent English language skills.
- Experience supporting inspection-readiness activities (FDA, HC & EMA) is a plus.
Additional Information
Deadline
Please apply before 31st March 2025. To submit your application, please upload your English version of CV (click on Apply and follow the instructions).
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