Quality Compliance Expert

Posté 08 mai 2023

Aubonne, Vaud - Switzerland

Demander un identifiant 260870


Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.


United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.


Your role: 


As member of the Quality System & Compliance group, you will


- Act as process owner for the site inspection / audit management and be responsible to:

               - lead site inspection / audit readiness, CAPA answer and AIDAR report

               - ensure inspection readiness for upcoming Pre-Approval Inspections associated to the introduction of the new isolator technology (SKY Project)

               - train subject matter experts


- Act as CCP coordinator and be responsible to:

               - support the process owner and change control process by ensuring monitoring, performing analysis and measurement of records to ensure compliance and                efficiency of that system and related documents

               - coordinate change control committee at site level


- Act as risk coordinator and be responsible to:

               - be risk facilitator for the Quality Unit department

- support Quality Risk Management activities

- provide technical guidance to perform QRM in the Quality Unit department

               - support the system / process owner and risk management exercise



- Continuous improvement of area under your responsibilities

- Automatization of routine tasks (with tools like Power Apps, Power Automate) and processus


As member of the Quality System and Compliance group, you will also participate or lead departmental and cross-functional compliance initiatives and Support continuous improvement of the Quality Management System (QMS)


Your profile: 


  • Excellent communication and presentation skills at different levels
  • Ability to work both independently and collaboratively, well-organized and structured with excellent technical and analytical skills.
  • Ability to drive collaborations with cross-functional teams to accomplish objectives.
  • Personal accountability for results and integrity.
  • Promote continuous improvement.
  • University degree (min Master) in scientific education.
  • 8 + years in pharmaceutical industry.
  • Experience in Health Authorities Inspections.
  • Experience in Quality Systems management.
  • Experience in manufacturing processes and with isolator technology
  • Fluent in French and English.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!