R&D QP Release Manager (CDI)
Rixensart, Belgium
6 dagen geleden

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In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a , we empower you to be yourself, share ideas and work collaboratively

R&D QP Release Manager

Are you looking for a QP role in an R&D challenging environment? Would you like to join a team of 10 persons doing the release and QP certification of vaccines candidates for use in clinical trials?

If so, this opportunity could be the perfect fit for your career!

Within the current framework of the Investigational Medicinal Product operations in R&D, we offer you to be in charge of a specific development portfolio and to be the first key contact regarding all release related questions for clinical batches of your perimeter.

You will be a key interface between internal departments : R&D Quality, Technical R&D, Regulatory, Clinical, Medical, Commercial operations and Global functions.

Finally, you will be the voice of the Qualified Person in any governing bodies either at local or global level.

In this role you will

  • Ensure, in due time, the QP certification and final release of GMP vaccine candidates intended to be used in clinical studies and ensure efficient and robust release systems and tools are in place.
  • In the area of responsibilities, ensure risks and critical issues are adequately managed; ensure identification and characterization, impact evaluation on quality, safety and efficacy of GSK products and potential impact on clinical data as well as on GSK business;
  • ensure timely escalation to upper management including remediation plan proposals.

  • Ensure the Product Specification Files edition and support the system in order to ensure that materials used in Clinical Trials are ordered, manufactured and released following approved Product Specification File (PSF).
  • Ensure and engage for review and effective execution of the Regulatory Submission and act as liaison between Technical R&D Quality and Global Regulatory Affairs for any regulatory related questions (including questions on Change Control / Deviation / PSF)
  • Represent QP / QA department positions / opinions views in all meetings related to the area of responsibility (staff meetings, project meetings, deviations, CAPA, CC follow-up meetings, ).
  • Support the nominated QP on a daily basis in all quality issues, QP related matters and QP related activities as needed including recall and complaint management.
  • Proactively identify and manage potential quality and business risks. Educate and influence by his behavior compliance to good quality practices.
  • Is a key spokeperson front line during regulatory inspection.
  • Ensure the R&D QP related systems are fit for purpose.
  • This job opportunity is a permanent contract, based in Belgium.

    Why you?

    Qualifications & Skills :

  • Industrial Pharmacist. The candidate must be QP certified by the Belgian MoH as stated by Belgian regulation : (DECEMBRE 2006.
  • Arrêté royal concernant les médicaments à usage humain et vétérinaire

  • 5-10 years in the Pharmaceutical / Biotech industry with significant experience of GMP within a major authority jurisdiction (EMA / FDA).
  • 5-8 years in a quality management position with additional experience in production and / or quality control

  • Deep understanding of the framework within which a pharmaceutical product has to be developed, registered, release and launched.
  • In-depth knowledge and understanding of international legislation and regulatory standards.
  • Deep understanding of the framework within which a Qualified Person operate
  • Preferred Qualifications & Skills :

  • Ability to make independent decisions even under pressure, ability to adapt, work under uncertainty and accommodate flexible work demands.
  • Strong interpersonal skills with demonstrated ability to engage, empower and influence people.
  • French speaker while being fluent in spoken and written English.
  • Ability to communicate complex information both orally and in writing.
  • Ability to evaluate product compliance and quality issues and make sound recommendations regarding problem resolution.
  • In depth understanding of cGMPs and regulations applicable to the Vaccine industry in the relevant countries. (FDA / EU / WHO and other countries);
  • Has the technical competencies to evaluate investigations, product issues.

    Our department :

    The R&D QP office manage the QP certifications of clinical material manufactured worldwide and intended to be used in clinical trials, as well as activities related to our IMP Manufacturing and Importation Authorization.

    The R&D QP Office is part of R&D Quality Department.

    If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

    Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible.

    Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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