We are seeking a Senior Manager, Supplier Quality, responsible for overseeing the quality management of procured materials (APIs, excipients, intermediates, packaging materials) in compliance with applicable internal and external requirements (GxP, ISO) while developing, implementing, and improving related systems, processes, and procedures.
What You Will Do:
* Drive the quality oversight of the allocated portfolio of procured materials throughout their lifecycle, ensuring the timely and effective implementation of the SANTEN operational management model, coordinating and following up on change requests and resolving any quality events to prevent recurrence.
* Identify and implement continuous quality improvement plans, monitor performance, follow up on audit CAPAs, and assess, prevent, and mitigate risks, while making and communicating appropriate, timely recommendations for quality decisions.
* Develop and implement quality agreements and other contractual agreements related to quality, manage supplier-related projects for quality aspects, and ensure the proper selection, qualification, or disqualification of suppliers, with effective oversight of suppliers' sterilization sites.
* Contribute to the development and implementation of state-of-the-art supplier management processes, procedures, tools, and best practices.
* Lead or participate in supplier external audits and selection visits, take responsibility for QP declarations and the material parts of Product Quality Reports.
* Compile API-related regulatory documents (including CE marking), and address queries from regulatory authorities.
* Lead cross-functional initiatives, proactively support colleagues and peers, and collaborate closely with other SANTEN entities and functions.
Qualifications
* Educational Background: A Bachelor’s degree in Biology, Pharmacy, Chemistry, Engineering, or a related field is essential for this role.
* Industry Experience: A minimum of 10 years of experience in the pharmaceutical industry, focusing on manufacturing and quality roles within global companies. Extensive experience managing external operations and suppliers across multiple countries, including APIs. Deep knowledge of API manufacturing and regulatory requirements for the pharmaceutical and medical device industries. Experience in leading supplier external audits and compiling API-related regulatory documents would be an advantage.
* Stakeholder Management: Proven ability to manage relationships with external suppliers and internal teams, ensuring effective collaboration across global functions.
* Communication and Collaboration: Fluent in English is required, with fluency in French being an advantage. Excellent communication and organizational skills, with the ability to work cross-functionally and collaborate across diverse cultures, particularly in Europe and Asia.
* Technical Proficiency: Advanced project management skills and proficiency in quality management systems such as TrackWise (QM), VeevaVault will be an advantage. Knowledge of sterilization processes is a plus.
Deadline
Please apply by 4th March, 2024.
To submit your application, please upload your English version of CV (click on Apply and follow the instructions) as we don’t accept CVs sent directly.
Additional Information
Grow your career at Santen
A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all 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 physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.
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