Senior Quality Cluster Lead Western Region/ / Responsible Pharmacist (Director)
Santen · Paris · €112,100–€154,130 (stated in the posting)
Company Description
Santen is a specialized company with a proud 130-year heritage focused exclusively on eye health. As a Japan-originated, global company with our footprint in over 60 countries and regions, our mission is to provide essential and significant value to patients and society through our products and services created from our expertise in ophthalmology and from the patient’s perspective.
Job Description
As Senior Quality Cluster Lead, you will lead and drive Quality oversight across Santen’s Western Europe cluster, covering France, Iberia and Italy. You will ensure continuous compliance with applicable pharmaceutical legislation, GMP, GDP, GVP and corporate Quality requirements, while strengthening Quality awareness and a culture of compliance, patient safety and continuous improvement.
You will act as the primary Quality interface between Manufacturing, Distribution and Commercial Operations, ensuring that products are developed, registered, distributed and maintained in compliance with regulatory and Quality standards. In France, you will also be responsible for the pharmaceutical operations of the Exploitant and for the relevant responsibilities related to marketed medical devices.
What you will do
- Lead Quality oversight across France, Iberia and Italy and ensure implementation and maintenance of an effective Quality Management System aligned with company, EMEA and local requirements.
- Act as the Quality subject matter expert for pharmaceutical legislation and Quality requirements, monitoring regulatory developments and translating them into actionable business requirements.
- Ensure inspection readiness and represent Santen in relevant interactions with Health Authorities, regulatory agencies and other external stakeholders.
- Oversee Quality risks, investigations, deviations, complaints, recalls and CAPAs, ensuring effective corrective and preventive actions.
- Provide Quality leadership for new product launches, distribution process changes and strategic projects.
- Partner with Regulatory Affairs, Pharmacovigilance, Medical Affairs, Supply Chain, Commercial, Marketing, Compliance, Market Access and other relevant functions.
- Lead or participate in Quality audits, inspections, supplier audits and risk assessments, and ensure appropriate Quality oversight of relevant external partners.
- Drive harmonization, continuous improvement and effective Quality metrics management across the cluster.
- Develop Quality awareness and promote a culture of compliance, accountability, patient safety and continuous improvement, including through training, communication and coaching.
- Lead, develop and coach the Quality team and manage the allocated budget.
Qualifications
What you will bring to the role
- Doctor of Pharmacy / Qualified Pharmacist with 10+ years of experience in a multinational pharmaceutical organization.
- Strong experience with the Quality system and pharmaceutical operations of an “Exploitant” pharmaceutical establishment in France, including French GMP, GDP and GVP requirements.
- Strong knowledge of EU GMP, GDP and GVP principles, pharmaceutical Quality systems and regulatory compliance requirements covering medicines and medical devices.
- Experience working with Health Authorities and regulatory inspections, with auditor qualification and audit experience.
- Strong understanding of the activities of an Exploitant and their interaction with Marketing, Sales, Supply Chain, Regulatory Affairs, Medical Affairs and Market Access.
- Demonstrated leadership in matrix and cross-functional environments.
- Good knowledge of the French medical visit certification requirements and relevant French pharmaceutical tools and processes is required.
- Experience with Quality and regulatory systems such as Veeva Vault, TrackWise and similar platforms is desirable.
- Fluent in French and English.
Ready to make a difference?
Apply today and help us shape the future of eye health.
What we offer:
- Competitive Salary: A market‑aligned base salary starting from €112 100.00 – €154 130.00, depending on experience and location.
Additional Information
- Grow your career at Santen
- A career at Santen is an opportunity to make a difference. We aspire to contribute to the realization of “Happiness with Vision” by providing eye health products and services to patients, consumers, and medical professionals around the world. Guided by our CORE PRINCIPLE, “Tenki ni sanyo suru”, Santen is engaged in the global research & development, manufacturing, and sales and marketing of pharmaceutical products in ophthalmology. 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.