Company Description
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 Description
Job's Mission
We are seeking an experienced API process and Supplier Management expert to lead the GMP compliance of APIs, excipients, and primary packaging materials used in Santen products. This role involves overseeing operational quality management, supplier compliance, and developing efficient supplier management systems within the SANTEN EMEA organization. You will serve as a senior compliance auditor, ensuring adherence to GMP/ISO standards, and play a key role in supplier oversight.
Key Responsibilities & Accountabilities
- Participate in or lead supplier external audits, due diligence visits, and manage overall QP declarations to ensure compliance with API, excipient, packaging, and sterilization standards.
- Oversee and coordinate global change controls for APIs, excipients, packaging materials, and sterilization sites, including follow-up and reviewing deviations, investigations, and CAPAs.
- Develop, implement, and continuously improve supplier management systems, procedures, and tools within the SANTEN EMEA organization, ensuring alignment with GMP/ISO standards.
- Manage and review Quality Agreements with third-party auditors, material suppliers, and service providers, including annual supplier risk assessments and monitoring supplier performance.
- Compile API-related regulatory documents and respond to queries from authorities, while supporting regulatory documentation preparation, including CE mark registrations for primary packaging.
- Provide quality oversight for sterilization sites of primary packaging materials, ensuring adherence to SANTEN standards and maintaining product quality reports.
- Lead cross-functional initiatives, collaborating with Santen entities and teams to meet regulatory expectations and proactively support team members in achieving quality objectives.
Qualifications
- At least 3-5 years of experience conducting GMP/ISO audits and good knowledge in API’s.
- Proven experience working in a multinational pharma environment for at least 5 years.
- Strong Supplier Management skills.
- Strong understanding of international regulatory requirements for pharmaceuticals and medical devices, with expertise in EU GMP regulations, relevant ISO standards, and EU MDR regulations.
- M.Sc. degree in pharmacy, chemistry, biology, or life sciences.
- Fluent in English; auditor certification is a plus.
Deadline
Please apply no later than December 2ⁿᵈ, 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.
What We Do
As a specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices. Santen is the market leader for prescription ophthalmic pharmaceuticals in Japan and its products now reach patients in over 60 countries. With scientific knowledge and organizational capabilities nurtured over a 130-year history, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society.
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