Capa Manager H/F

Groupe Servier
Gif-sur-Yvette, France
about 2 months ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Languages
English

Tech stack

Microsoft Excel Microsoft Office Microsoft PowerPoint GXP

Job description

Are you a fast-learning professional passionate about quality, compliance, and continuous improvement in life sciences? We are seeking a CAPA Manager to join our Quality department. In this role, you will support the strategic and operational management of the Corrective and Preventive Action (CAPA) system to ensure regulatory compliance and process integrity., Provide cross-functional oversight of the CAPA system, ensuring overall integrity of the CAPA process

  • Establish and maintain procedures, training, and tools for effective CAPA management
  • Ensure company compliance with international standards and regulations for CAPA management
  • Drive continuous improvement: analyze CAPA trends, identify opportunities to enhance quality processes, and foster a culture of excellence
  • Oversee and manage CAPAs related to deviations from any origin (routine controls, internal/external audits, inspections)
  • Monitor CAPA due dates with responsible stakeholders to ensure actions are implemented within agreed timelines
  • Review evidence of CAPA completion for final acceptance and formal closure in the CAPA Management System
  • Monitor Effectiveness Check (EC) plan due dates when applicable; review evidence of completion and assess outcomes for acceptance and closure of related deviations and CAPA plans
  • Escalate any overdue CAPAs/EC plans to Servier staff in charge, if applicable
  • Contribute to all CAPA-related activities: document archiving, PSMF updates, tracking and database maintenance, trend analysis, metrics reporting, and inspection readiness
  • Perform other tasks or projects as delegated by the manager

Requirements

Master’s degree in a scientific field (preferably Master 2 in Quality Management or Master 2 in Quality Control of Health Products)

  • Prior experience in Quality
  • Knowledge of quality management frameworks (GxP, ISO, etc.)
  • Proficient in English
  • Strong Microsoft Office skills (PowerPoint, Excel, etc.)
  • Excellent communication skills and interpersonal abilities
  • Proven decision-making and problem-solving capabilities
  • High rigor, organization, and responsiveness
  • Strong listening skills; ability to work autonomously
  • Initiative and a proactive approach

Benefits & conditions

Our recruitment process:

  • Prequalification Interview
  • Interview with the Manager
  • Interview with Talent Acquisition Team / Human Resources
  • Reference Check Process

At one stage of the process, we would be delighted to welcome you to our site to meet in person and share the environment where we work every day to transform patients’ lives!

Please note that this recruitment process may be adapted based on the specific requirements of the position.

Our Benefits:

  • 13th-month salary, contribution to results bonus, profit-sharing / employee participation, and transportation allowance
  • 27 days of paid leave, plus 23 RTT days (reduced working hours)
  • Supplemental pension plan, health insurance with 60% company contribution, and a comprehensive provident scheme
  • Flexible remote work options depending on the role
  • On-site company restaurant, and a wide range of employee committee (CSE) activities and associations

We are committed to equal opportunities and developing talents in all their diversity. We value both experience and the desire to engage daily in contributing to therapeutic progress for the benefit of patients. If this offer resonates with you, seize this opportunity to meet us!

About the company

We are a global and independent mid-sized pharmaceutical group governed by a Foundation. Our unique model makes us proud and, more importantly, enables us to fully serve our mission: ā€œcommitted to therapeutic progress for the benefit of patients.ā€

As a global leader in cardiology, we aim to become a focused and innovative player in oncology by 2030, targeting hard-to-treat cancers and dedicating more than 70% of our R&D budget to this goal.

Who are we? 20,000 passionate individuals from over 50 nationalities, driven by an entrepreneurial spirit. Every day, we move forward with and for patients, with and for our teams, motivated by the desire to care, to dare, to grow, and to commit to being useful to those in need.

Come and experience and contribute to our commitment #MovedByYou.

www.servier.com

About our R&D Institute in Paris Saclay:

At the heart of one of the world’s top eight innovation clusters, the Servier R&D Institute at Paris-Saclay is where visionary science meets a powerful global ecosystem. By uniting our Group’s innovation potential with this prestigious center of excellence, we are not only accelerating the future of therapeutic discovery but also championing the global influence of French research., We are a global and independent mid-sized pharmaceutical group governed by a Foundation. Our unique model makes us proud and, more importantly, enables us to fully serve our mission: ā€œcommitted to therapeutic progress for the benefit of patients.ā€As a global leader in cardiology, we aim to become a focused and innovative player in oncology by 2030, targeting hard-to-treat cancers and dedicating more than 70% of our R&D budget to this goal.

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