Job's Mission
- To be responsible for GMP compliance of APIs and excipients and GMP/ISO standards of primary packaging materials and their sterilization sites used in Santen’s products
- To be responsible for the operational quality management for the materials and related deviations, change controls and QA Agreements.
- To work as the senior compliance auditor for the materials and related service providers and as QA expert in the area
- To develop and drive the efficient supplier management systems, procedures and tools in SANTEN EMEA organization
Key Responsibilities & Accountabilities
- Where required, to participate to, or lead supplier external audits and due diligence visits (APIs, excipients, primary packaging materials, sterilization sites…)
- To be responsible for overall management of the QP declarations
- To coordinate globally APIs, excipients, primary packaging material and sterilization sites change controls and take an overall responsibility for follow-up.
- To review the deviations, investigations and CAPAs for APIs, excipients, primary packaging materials and sterilization sites
- To support materials’ annual supplier risk assessments
- To be responsible for the Quality Agreements with the 3rd party audit companies, material suppliers and service providers
- To be responsible for developing the supplier management systems, procedures and tools in SANTEN EMEA organization
- To monitor the supplier performance and drive continuous improvement
- Compilation of API related regulatory documents and answering to queries from the competent Authorities worldwide
- Where required, to support the regulatory documentation preparation including CE mark registration for primary packaging materials for combined products
- To be responsible for Material parts in the Product Quality Reports
- To quality oversight the sterilization sites of the primary packaging materials under SANTEN responsibility
- To lead cross-functional initiatives, to proactively support other team members where needed
- To work closely and effectively liaise with other Santen entities and functions to meet intra-company regulatory expectations
- A minimum of 8-10 years experience working in a pharmaceutical industry, preferably in Quality Assurance/Quality Control, Regulatory Affairs or related area
- Experience of GMP/ISO audits at least 3-5 years
- Excellent knowledge and understanding of international regulatory requirements in pharmaceuticals and medical devices
- Deep knowledge of EU GMP regulations, related ISO standards and EU MDR regulations
- Experience of working in a multinational environment at least 5 years
- M.Sc. education in pharmacy, chemistry, biology or life science
- Fluent English
- Nice to have: Auditor certification
- please only apply if you are located in EU
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.
