Manager CMO Quality Lead (EMEA) at Santen

Paris, Ile-de-France, France -

Full Time

Start Date

Immediate

Expiry Date

28 Jun, 26

Salary

0.0

Posted On

30 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Oversight, Contract Manufacturing Organizations (CMOs), Pharmaceutical Products, Biologic Products, Deviation Management, Investigation Management, CAPA Management, Regulatory Inspections, Aseptic Manufacturing, EU GMP Requirements, Change Control, Quality Agreements, KPI Monitoring, TrackWise (QM), Veeva Vault, MS Office

Industry

Pharmaceutical Manufacturing

Description

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 To act as the Santen Quality interface for assigned Contract Manufacturing Organizations (CMOs) and partners in EMEA, ensuring effective operational quality oversight and coordination for externally manufactured pharmaceutical products and biologic products. The CMO Manager Lead will work closely with the Sr Manager CMO Lead. What you will do Coordinate and support quality management of assigned CMOs and partners, acting as the Single Point of Contact (SPOC) for operational quality topics within the cross-functional CRM team, ensuring effective triage, communication with accountable Product Quality owners, and timely escalation of business risks to the line manager. Provide support to the Product Quality team for deviation, investigation, and CAPA management, including follow-up of CAPAs from CMO audits, representation of Quality in relevant forums as delegated, and support during regulatory inspections under senior QA guidance. Oversee quality aspects of external manufacturing operations, including on-site QA presence for validations or activities requiring independent witness when applicable, and support product transfers, line changes, new packaging lines, and other manufacturing changes at CMOs under supervision. Contribute to New Product Introduction (NPI) and territory expansion activities for externally manufactured products, coordinating change control activities with NPI and Product Quality teams. Maintain and update Quality Agreements with CMOs, prepare drafts and revisions for review and approval, support implementation and monitoring of quality KPIs, prepare inputs for CMO Quality Reviews and annual risk management activities, and organize and coordinate regular quality meetings including agenda preparation, documentation, action tracking, and follow-up. Qualifications 7–10 years of experience in the pharmaceutical industry, including at least 5 years in aseptic manufacturing within a multinational environment. B.Sc. or M.Sc. in Biology, Pharmacy, Chemistry, or a related scientific discipline; fluent in English (written and spoken) with French required for interaction with French CMOs. Strong knowledge of biologics manufacturing, including drug substance production and cell banking, with a solid understanding of sterile/aseptic processes and EU GMP requirements. Experience working with Contract Manufacturing Organizations (CMOs) and within cross-functional, matrix organizations. Structured problem-solving skills with sound judgment and the ability to manage multiple operational topics in parallel. Strong collaboration and relationship-building skills in an international environment; proactive, flexible, well-organized, and detail-oriented. Advanced proficiency in MS Office (Word, Excel, PowerPoint, Outlook, SharePoint, Visio) and strong user experience with TrackWise (QM) and Veeva Vault. 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.

Responsibilities

The role involves acting as the Quality interface for assigned Contract Manufacturing Organizations (CMOs) in EMEA, ensuring operational quality oversight for externally manufactured pharmaceutical and biologic products. Key duties include coordinating quality management, supporting deviation/CAPA processes, overseeing external manufacturing quality aspects, and contributing to New Product Introduction activities.