Senior Quality Cluster Lead Western Region Responsible Pharmacist (Director)

As Senior Quality Cluster Lead you will lead and drive Quality oversight across Santens 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 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 marketaligned 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.

Remote Work :

No

Employment Type :

Full-time