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Danone's Research & Innovation (R&I) center, located in Gif-sur-Yvette on the Saclay plateau, is a global center of excellence dedicated to food innovation. Inaugurated in 2023, this state-of-the-art center is at the heart of one of the largest international scientific clusters. It houses more than 500 experts from 40 nationalities passionate about life sciences, nutrition, consumer experience, pilots, and product design. Danone's R&I center is designed to foster collaboration with food tech startups and accelerate innovation in partnership with consumers and partners around food and health
The Medical & Nutritional Science (M&NS) department is hiring a Senior Manager Quality Clinical Studies on a permanent contract in the Clinical Research team. The position is based in Gif-sur-Yvette on the Saclay plateau at the Danone Global Research & Innovation Center Daniel Carasso, which is at the heart of Danone's Research & Innovation. The center comprises state-of-the-art laboratories and pilot workshops, with employees working collectively to innovate on dairy and plant products, waters, and specialized nutrition for the future.
The M&NS department aims to create value and growth opportunities for Danone around Nutrition and/or Health. The department includes teams based in the Netherlands (Utrecht), France (Gif-sur-Yvette), and Singapore.
MISSIONS
We are looking for a Senior Manager Quality Clinical Studies to join our team.
The Sr Quality Manager is responsible for implementing and maintaining quality assurance and quality control systems to ensure that clinical studies are conducted in compliance with applicable regulatory requirements and industry standards (e.g. ICH-GCP, GDPR).
The Sr Quality Manager responsibility includes the coordination of audits, compliance checks, maintenance of the Quality Management System (Standard Operating Procedures, supporting documents) and the coordination of related training.
The Sr Quality Manager provide advice those working on clinical studies with regards to quality related topics and questions.
The Sr Quality Manager reports to the Senior Team Leader Quality clinical studies & evidence capabilities, based in Utrecht, The Netherlands.
Main Responsibilities:
- Define, manage, and maintain the quality management system for clinical studies in close collaboration with the quality team members based in the Netherlands. This includes:
- Managing the quality management system with a continuous improvement approach, support maintenance of the ISO9001 certification and preparation of the Quality Management Review meeting.
- Document management: developing, implementing, and maintaining Quality System documents in compliance with current standards (ICH-GCP, ISO 9001), and legal (e.g., GDPR), ethical, scientific, and methodological requirements of Danone.
- Ensure process role-based training curricula are available, engage stakeholders to utilize processes, drive a strong culture of quality. Coordinate training (meetings and materials) related to the QMS or regulations. Managing training follow-up related to clinical processes.
- Aligning the system with business strategy and regulatory requirements. Monitoring regulatory developments within the framework of applicable local and international regulations and Good Practices.
- Conducting quality control activities for essential clinical study documents, contribute to risk assessments on study level, and quality consultancy in data review meetings.
- Supporting the implementation of the annual audit plan and its follow-up, risk management, monitoring non-conformities, and associated CAPAs. Ensure escalation where needed (incident management).
- Ensure audit readiness, propose external auditors, coordinate independent audits and compliance checks by internal staff, perform quality reviews.
- Supporting the evaluation of performance indicators and managing the annual activity.
About you
- Higher education background in science or the food industry (minimum Master's in Life Sciences, Biology, Pharmaceutical Industry, or PharmD).
- Several years of experience in clinical studies, particularly in quality, with good regulatory knowledge in the field of clinical studies, ICH GCP, ISO 9001, and GDPR.
Skills:
- Rigor and organization.
- Ability to work in a team, good listening skills, and excellent interpersonal relationships.
- Excellent communication skills to interact with internal multidisciplinary project teams.
- Analytical, synthesis, and writing skills.
- Dynamic and pragmatic.
- Fluency in English (Cambridge level C 1 or 2), and preferably in French.
- Proficiency in office tools (Office Pack, Visio).
- Able to motivate and train employees to work with the Quality Management System.
Danone is proud to promote inclusion and equal opportunities. We truly believe that our diversity will make the difference and that an inclusive environment will make us grow as a company, as a team, and as people. We therefore consider all applications* to ensure an inclusive corporate culture where everyone can feel like they belong.
- All applications will be considered irrespective of origins and ethnicity, personal background, religion, gender, sexual orientation, age, disability.
At Danone, we guarantee that you can simply be yourself. We believe that it's up to you to define the way you work, to develop yourself, to progress. With us, you'll work in an exciting, complex, and challenging environment. This is how you will create new opportunities! You will work with world-renowned brands such as Blédina, Evian, or Actimel. Be innovative, enterprising, and the impact you will have will impress you. Join our movement for a more sustainable world. One Planet One Health BY YOU.
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