Clinical Development Quality Lead

Vor 7 Tagen

Schweiz Aixial Vollzeit

Clinical Development Quality Lead (M/F)



Location: Lausanne, Switzerland

Who is Aixial Group? Aixial Group is a CRO (Clinical Research Organization) specializing in Life Science. We collaborate with laboratories to provide technical support on clinical projects from phases I to IV and post market. Since 2014, we have been part of the Alten family. We are expanding our activities internationally in Switzerland, France, Belgium, Czech Republic, Denmark, UK, and beyond. Aixial Group operates in various areas such as clinical operations, regulatory affairs, quality, biometrics, pharmacovigilance, HEOR, and more. Our team is growing, and we are seeking individuals to join us in the clinical trial professions.

Come and be a part of our exciting journey at Aixial Group Switzerland as we search for the next Clinical Development Quality Lead (M/F).



MISSION:

The Clinical Development Quality Lead (M/F) contributes to the implementation of the Quality Strategy to support International's day-to-day clinical trial activities. This role focuses on a cross-functional end-to-end perspective, utilizing proactive quality principles and providing continuous support during Clinical Development Activities.



YOUR RESPONSIBILITIES:

  • Develop a tailored compliance program to ensure document/data accuracy, emphasizing dossier acceptability.
  • Participate in CRO/Vendor selection to establish a proactive quality approach and ensure regulatory compliance.
  • Collaborate with the Study Team to oversee outsourced CRO activities and critical data points.
  • Provide compliance support and oversee quality events that could impact the clinical study's validity.
  • Contribute to the development and review of critical clinical study documents for consistency.
  • Identify the need for co-auditing activities and conduct quality visits.
  • Act as an internal advisor on procedures and regulations, creating areas for improvement based on compliance activities.
  • Lead Regulatory Authority Inspections and Due Diligence Activities.
  • Build relationships within the study team and drive a culture of compliance.
  • Support the execution of Master Audit Plan and assist in CAPA formulation and follow-up.

Support the development/maintenance of QM and ClinDev related Procedural Documents.



YOUR PROFILE:

  • University Degree in Sciences or relevant academic background.
  • 6-8 years' experience in the pharmaceutical/biotech industry, including 3 years in Clinical Quality Management System & Compliance.
  • Experience in managing GCP audits and strong knowledge of regulatory guidelines.
  • Experience in QA vendor oversight, SOPs, and computerized systems validation.
  • Strong organizational skills, flexibility, and dedication to continuous improvement.
  • Fluency in English, French is a plus.

Why Join Us?

Make a positive impact in clinical research, contributing to advancements that benefit millions of people globally.


Career Development:

We are committed to empowering our team, fostering growth, flexibility, and teamwork.

Receive coaching and mentoring to support your professional and personal growth.


Our commitment to Diversity, Equality, and Inclusion:

We strive to create a diverse and inclusive workforce where individual differences are recognized and valued.

Gender equality is central to Aixial Group's development strategy.

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