Scope

We assist our clients through non-clinical and clinical studies to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.

For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

Your mission

You will report to the R&D Director.

In this role you will promote the continuity and development of Quality Assistance’s activities within the biopharma market.

This implies:

  • Ensuring regulatory watch for Cells / Advanced Therapy Medicinal products

    • Attending scientific and regulatory meetings, conferences, webinars, etc.

    • Keeping informed of upcoming regulatory texts, and transcribing the regulatory requirements into Quality Assistance procedures.

    • Gathering technical and scientific information obtained internally (Scientific Operations, Sales) and externally (customers, newsletters, bibliography, conferences, webinars).

  • Monitoring the progress of R&D projects related to Cells / Advanced Therapy Medicinal products

    • Supporting the R&D Director and the R&D Technical Leaders in method development, troubleshooting, and bibliographical search.

    • Ensuring that the related communication material is always up-to-date as regards to new equipment, R&D projects, new regulatory guidelines, etc.

  • Upon request, supporting the Scientific Operations Department (SO) in terms of:

    • Support for method development, data interpretation, troubleshooting, bibliographic searches.

    • Supporting and advising on the preparation of development, transfer and validation protocols.
    • Scientific review of reports and participation in technical meetings with customers.
  • Mapping, developing, and maintaining a strong network with external stakeholders and understanding their needs

    • Representing Quality Assistance at international conferences.

    • Supporting the Sales team

      • Being the primary advisor for the sales team in taking part in technical and business discussions with the customers.

      • Being the main contact point between the sales team and operations team.

      • Targeting and soliciting internal experts in order to provide a response adapted to the client's needs.

    • Discussing with suppliers to clearly define Quality Assistance needs and meet the clients’ needs.

    • Attending the meetings of internal groups of experts focused on the key analytical techniques used for the product.

  • Working closely with Knowledge Management team to identify training needs to maintain and build up technical, scientific and regulatory expertise of QA staff members

    • Providing training on the product, techniques.

    • Writing and updating training documentation on the product.

  • Supporting Technics Department

    • Being involved in the investment of new equipment dedicated to the analysis of the product.

    • Helping in the preparation of URS and DQ for new equipment.

Your profile

Scientific background (PhD or Master's degree / Engineer)

Required

  • Excellent knowledge of drug development workflows and of all the general pharmaceutical guidelines.

  • Experience in literature review and analysis.

  • Excellent oral and written communication skills.

  • Excellent knowledge of key aspects of Cells / Advanced Therapy Medicinal products (production, pharmaceutical development, mode of action).

  • Excellent knowledge of all product-specific guidelines.

  • Analytical expertise

    • Excellent knowledge of all the analytical techniques required for the characterisation and analysis of the product.

    • Hands-on experience on part of key analytical techniques used for the product.

Why join Quality Assistance?

We are a true career partner.

  • We accelerate people’s access to new medicines.

  • We offer an inspiring work-life balance in a human scale environmeant.

  • We care about mutual respect, assistance and communication.

  • We listen to your needs and your suggestions.

  • We offer a market-competitive remuneration package including numerous fringe benefits.

Visit https://www.quality-assistance.com/quality-assistance/life-quality-assistance to learn more.

About Quality Assistance

Quality Assistance is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products.

We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences. 

For each client project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

The company holds a unique position on the market with all its laboratories on one site, 220 highly qualified professionals and over 35 years’ expertise at the forefront of analytical sciences.

The Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.

Visit https://www.quality-assistance.com/quality-assistance/leading-analytical-cro to learn more.

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