Quality Assurance Manager for Clinical and Pharmacovigilance
il y a 4 semaines
About the Role
Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.
Job Summary
We are seeking a highly skilled Quality Assurance Manager to assist with Clinical quality and Pharmacovigilance/Safety vigilance—quality processes oversight in Santen SAS, EMA, and APAC regions. The successful candidate will have a strong understanding of GCP and GPvP regulations and will be responsible for ensuring compliance with these regulations.
Key Responsibilities
- Assist with oversight of Quality and compliance with clinical development projects, products, and programs.
- Work in collaboration with the Clinical Department, Pharmacovigilance/Safety Vigilance EMEA, APAC, and other functional areas as needed on the implementation of the Santen Quality Management System.
- Provide guidance to Clinical Operations, Data Management, clinical supply, and Drug Safety to develop their self-inspection activities.
- Support Clinical Operations with quality-related issues and provide guidance when necessary.
- Ensure patient safety and rights in compliance with applicable regulations by providing continuous support to clinical teams during the project lifecycle.
- Assist with conducting study-specific eTMF audit for inspection readiness.
- Implement and maintain the Quality Management System in the GCP area in accordance with the local and global requirements.
- Develop, maintain, and follow up quality metrics for GCP in collaboration with Clinical Operations, Data Management, and Drug Safety.
- Develop and implement global clinical trials GCP audit plan using a risk-based approach.
- Conduct internal GCP audits as scheduled or to outsource them when time conflict occurs.
- Perform QA assessment of Contract Research Organizations and external service providers.
- Conduct and/or supervise qualified auditors in scheduling, conducting, reporting, and following up audits as planned.
- Prepare and deliver periodic reports based on metrics and quality trends.
- Ensure that deviations and incidents are properly identified, managed and timely escalated when required.
- Based on audits and document review to provide guidance in determining root causes and ensure that appropriate corrective and preventive actions are efficiently implemented.
- Participate in all health authority inspections at Santen sites as part of the global QA team.
- Conduct GCP training for R&D employees according to company policy.
- Ensure readiness for GCP and GPvP inspections.
Requirements
- Minimum of 10+ years' experience in Clinical Quality Assurance and/or GPvP Assurance.
- Bachelor's degree in the scientific field or related healthcare provider (i.e., RN, Pharmacist PharmD). Advanced degree is a plus.
- Excellent understanding and practical application of domestic and foreign regulations and requirements regarding GCP and GPvP.
- Demonstrated experience preparing for regulatory inspections required.
- Excellent technical knowledge of GCP QA, GPvP QA, and quality assurance techniques.
- Strong interpersonal skills and the ability to work effectively in a cross-functional environment.
- Excellent written/oral communication and presentation skills.
- Strong organizational, time management, and project management skills.
- Proficient in the Microsoft Office software suite and other relevant computer applications.
- Computer system validation experience preferred.
About Santen
A career at Santen is an opportunity to make a difference. We are committed to being a Social Innovator, addressing the social and economic needs of people with visual impairments. We believe in empowering our team members with flexible ways of working and a highly inclusive work environment.
The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive workplace for every one of our team members.
If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.
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