At Danone, we are driven by a shared mission: bringing health through food to as many people as possible. Within the Clinical Evidence & Biometrics (CEB) team, you will play a key role in safeguarding quality and compliance across our clinical studies, helping us generate the evidence that powers our nutrition and health innovations.

As Senior Manager Quality Clinical Studies, you will design, maintain, and continuously improve the Quality Management System (QMS) that supports our global clinical research activities. You will be the go‑to expert for GCP, GDPR, ISO9001 and global regulations — ensuring our studies meet the highest scientific, ethical, and regulatory standards.

You will lead independent audits, support study teams with quality guidance, drive cross‑functional process improvements, and help shape a strong, future‑focused quality culture across CEB. This role is influential, strategic, and central to how Danone delivers clinical evidence with integrity and excellence.
This position reports to the Senior Team Leader Quality Clinical Studies & Evidence Capabilities.

Key Responsibilities

• Own and evolve the Quality Management System, ensuring continuous improvement, maintaining ISO9001 certification, and preparing the annual Quality Management Review.
• Develop and update Quality System documents aligned with global regulatory, ethical, scientific, and methodological standards.
• Ensure role-based process training is in place; coordinate QMS and regulation-related trainings and ensure follow‑up and compliance.
• Monitor regulatory developments and ensure alignment between processes, business strategy, and global requirements.
• Conduct quality control activities for essential study documents, support study-level risk assessments, and contribute quality insights during data review.
• Lead the management of non‑conformities and CAPAs, including correct escalation and incident management.
• Implement and coordinate the annual audit plan, ensuring audit readiness, proposing external auditors, and driving internal compliance reviews.
• Support performance indicator evaluations and contribute to the annual management review.
• Work closely across CEB (Clinical Operations, Data Management, Statistics), M&NS teams, laboratories, legal, finance and procurement, as well as teams involved in study product production.

You bring strong expertise in clinical research quality and you’re motivated to help shape quality excellence within nutritional clinical development. You thrive in a dynamic, science‑driven environment and enjoy partnering with cross‑functional teams to embed a strong quality mindset.

What you’ll need to succeed

• Master’s degree in Life Sciences, Biology, PharmD or related fields.
• Significant experience in clinical studies, particularly within quality assurance.
• Deep knowledge of ICH‑GCP, ISO9001, GDPR and regulatory frameworks for clinical research.

Skills & Competencies

• Strong expertise in quality management, able to independently solve complex problems and make sound decisions.
• Ability to drive organizational culture change and lead quality initiatives without formal people management responsibilities.
• Holistic understanding of organizational processes and the external landscape.
• Excellent stakeholder engagement, communication and relationship‑building skills.
• Strong analytical, synthesis and writing abilities, combined with a pragmatic and proactive mindset.
• Fluency in English (C1/C2). Dutch is a strong advantage.
• Proficiency in Office tools (Office Pack, Visio).
• Ability to motivate and train others to effectively use the QMS.