QA Senior Manager CMO Lead EMEA

Santen Inc; Paris; Sur place; EUR 50 000 - 80 000; Plein temps

Résumé du poste

Santen Inc seeks a Quality window person for their EMEA operations, focusing on quality oversight for medical device and pharmaceutical products. The role demands strong expertise in the pharmaceutical sector, particularly in aseptic processes, and involves coordination with various CMOs. Candidates should have at least eight years of relevant experience and excellent project management skills, with fluency in English as a prerequisite.

Qualifications

• 8–10 years of experience in the pharmaceutical industry, especially in the aseptic area.
• Solid knowledge of EU GMP, sterile manufacturing, and ISO 13485 standards.
• Fluent in English; French desirable.

Responsabilités

• Act as the Single Point of Contact for quality matters.
• Lead quality oversight for external manufacturing operations.
• Manage quality input for new product introductions and transfers.

Connaissances

Project Management

Stakeholder Communication

Cross-Functional Collaboration

Problem-Solving

Outils

MS Office

TrackWise

VeevaVault

SAP

Description du poste

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.

Job Description

To work as Santen Quality window person to your CMO and partners’ portfolio in EMEA for Medical devices and Pharmaceutical products.

What you will do

• Act as the Single Point of Contact for all operational quality matters with assigned CMOs and partners in EMEA.
• Lead quality oversight for external manufacturing operations, including validation support and escalation of critical issues.
• Drive and manage deviation investigations, CAPA, and change controls in collaboration with the Product Quality team.
• Coordinate and support New Product Introduction-related change controls, territory expansions, and product lifecycle management.
• Oversee quality aspects of product transfers, line changes, and new packaging introductions.
• Lead or participate in quality meetings (internal and external), including SRT, supply, and CMO business reviews.
• Support audits and inspections, follow up on CAPAs, and contribute to annual CMO risk assessments and reporting.

Key Responsibilities & Accountabilities

• Coordinate and lead quality activities for assigned CMOs, including deviation management, CAPA, and change control.
• Provide onsite validation support when independent quality oversight is required.
• Liaise with internal teams to ensure smooth communication and alignment with business needs.
• Manage quality input for new product introductions, product transfers, and packaging changes.
• Oversee and maintain QA agreements with CMOs, ensuring timely updates and accurate documentation.
• Define and report on quality performance metrics for CMOs.
• Represent Quality in cross-functional forums : SRT, NPI meetings, supply chain calls, and quarterly reviews.
• Support and follow up on audit-related CAPAs and provide input for inspections or Notified Body audits.
• Organize and lead internal meetings between product teams and CMOs to ensure quality expectations are met.

Qualifications

• 8–10 years of experience in the pharmaceutical industry, with strong experience in aseptic area within a multinational environment.
• Solid knowledge of EU GMP, sterile aseptic manufacturing, and ISO 13485 standards.
• Proven skills in project management, stakeholder communication, and cross-functional collaboration.
• Ability to handle complexity with proactive problem-solving, flexibility, and precision.
• Advanced proficiency in MS Office, TrackWise, and VeevaVault; SAP experience is a plus.
• Fluent in English; French is desirable for communication with local CMOs.

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.