Lead, Quality Management System EMEA

Santen Inc
NL - North Holland - Amsterdam
December 4, 2024
IT

As a global specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices that benefit patients in over 60 countries. Santen's long-term vision is to become a social innovator in ophthalmology and address social and economic issues related to eye health by strategically exploring advancing technologies and collaborating with key leaders around the world. Underpinned by its people-centric values, Santen aims to ultimately deliver happiness with vision - a life with the best vision experience for every individual around the world. With scientific knowledge and organizational capabilities nurtured over 130 years, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society.
Santen is in an exciting phase of growth with a market leading portfolio of products in glaucoma and dry eye treatment - areas in which our portfolio serves every stage and type of disease. We are also growing our range in eye infections, allergies, and devices for vision correction and glaucoma surgery.
This is an exciting time for us and we want exceptional people to be a part of it. More than just a part of it - we want your talent to drive our growth and grow with us. Because it's our people that make our vision a reality; it's their passion, creativity and expertise that makes a difference to patients' lives, every day.
If you're motivated by new opportunities, if you're ready for new challenges, and if you believe in doing business responsibly and staying true to your values, you may be the perfect candidate for a role at Santen.
JOB'S MISSION
Lead Santen EMEA Regional Quality Governance Activities to ensure that EMEA Quality Management System (QMS) processes are working properly and continuous improvement is achieved.
Lead EMEA Quality Audit Management. Rollout of consolidated supplier risk assessment and audit plan (CMO, API, GDP, ISO).
Support EMEA Learning Management System activities including GxP/ISO Training.
Play key role in quality management system related activities to ensure continuous compliance of Santen EMEA to applicable EU pharma, distribution and medical devices regulations (EU GDP, MDD/MDR, ISO13485).
KEY RESPONSIBILITIES & ACCOUNTABILITIES
In alignment with Santen vision and with EMEA Quality strategy, objectives and directions, and in compliance with any external or internal regulatory requirements:

To lead and support activities and projects related to the development, standardization, implementation, monitoring and continuous improvement of the EMEA Quality management system ensuring:

Robust best-in-class, standardized policies, procedures, guidelines and models.
Effective and efficient roll-out and monitoring across all EMEA entities.
To manage consolidated EMEA Quality Audit Plan to achieve:

Health Authority Inspection Readiness in EMEA
Qualified EMEA Auditor Pool
To support quality operational tasks and cross-functional projects related EMEA Quality Management System (QMS) in connection with EMEA Director QMS and IT quality.
Qualifications EDUCATION
B.Sc or M.Sc in chemistry, pharmaceutical, biotechnology, or life science area.
GxP experience and Quality Management System (QMS) knowledge.
Project Management.
EXPERIENCE
Use of Microsoft office tools.
5+ year experience of working in Pharmaceutical, Medical Device industry or related area.
e-QMS tools:
Veeva Vault, Trackwise.
Enhanced IT system skills.
SAP.
Additional Information Strategic thinking.
Analytical skill.
Excellent communication skills including ability to present to senior management.
Curiosity, Initiative, Passion for the business.
Cross functional project management skills.
Ability for problem identification and solving.
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Read the full job description and apply online on the recuiter's web-site

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