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Quality Assurance Manager

Quality Assurance Manager

Viroclinics BiosciencesGhent, Vlaams Gewest, Belgium
30+ dagen geleden
Functieomschrijving

As the Quality Assurance (QA) Manager  you are responsible to drive and ensure patient safety, data integrity and compliance with the relevant regulations and internal Cerba Research processes covering the clinical laboratory and diagnostic solutions part of clinical trial protocols, in close collaboration with the Scientific and Project Management Teams.

We are Cerba Research, a global partner for integrated clinical laboratory and diagnostic solutions. We help accelerate therapies through the development of highly specialized custom assays, deep biomarker expertise, and a passion for scientific innovation across complex therapeutic areas.

It is our mission to improve global health, together with our highly valued employees. Do you want to be part of our mission and join in the role of QA Manager?

In your role you will be responsible to :

Proactively implement ICH GCP and CGLP principles within Cerba Research teams by :

  • Contributing to Clinical Trial Risk management implementation with the Project Management and Scientific team.
  • Advising on quality questions related to clinical trials, laboratories and diagnostic solutions.
  • Ensuring incident and client complaints are appropriately reported, escalated and resolved
  • Train and advise CR team on Incident, audit report findings resolution by effective root cause analysis and CAPA definition.
  • Ensure training of personnel concerning QMS elements, applicable quality guidelines, IATA, HIPAA and local safety regulations (if applicable)

Establish and maintain excellent partnership and collaboration with our clients by :

  • Hosting Audits and respond to audit reports
  • Preparing quality agreements and maintain QA to QA communication.
  • support the operations Team and oversee issues being promptly reported to the client.
  • Proposing or develop jointly CAPAs to the client and ensure adequate and on time follow up.
  • Managing diligently client complaints and ensure on time and quality resolution.

    • Interact with Laboratory and diagnostic solution QA counterpart to ensure :

  • Adequate staff training and awareness of GCLP and data integrity requirements and clinical trial protocol related risks.
  • Review and approval of validation of laboratory tests.
  • Follow up of laboratory incident and CAPAs.
  • As a global QA team member contribute as a Subject Matter Expert in several QMS elements and processes (Audit, Vendor Qualification, Validation, Procedural Documents, Incidents, CAPAs) and become an expert in our Veeva QMS system.

    • The QA Manager is an ambassador for quality, both within and outside of the department. This position enjoys building relationships and working together collaboratively with others to meet shared objectives. This role is part of a team of QA professionals who strive to embed a quality culture across the organization, energized and motivated by teamwork in a positive and supportive working environment.

  • Master’s Degree in science preferred or equal by experience
  • Extensive knowledge and practical hands-on experience in GCP and CGLP and applicable legislation in Central Lab
  • Comprehensive understanding of pharmaceutical regulatory requirements and impact

    • on the various functions within the business

  • Strong experience in ICH GCP clinical trial or central lab role including quality assurance and quality management related responsibilities
  • Experience in international Clinical trial or Central Lab projects
  • Experience in using or managing QA clinical trial Data Management and CTMS databases
  • Excellent communication skills and teamwork
  • Flexible in dealing with problems and solution oriented
  • Punctual and having eye for details
  • Fluent in English (written and spoken language)

    • Working at Cerba Research

    Cerba Research is growing fast on a global scale. Working at Cerba Research first of all means that you contribute to improve global health. It also means growing your career in a dynamic, fast paced environment, where you can develop new skills and work on diverse projects. There is plenty of room for initiatives, we encourage you to take ownership, cooperate, keep learning and most and for all, have fun! Working at Cerba Research also comes with its challenges and it’s not for everyone.

    Sounds like you? Then we would love to meet you!