Job purpose:
As a QP office Specialist, you prepare, coordinate the review and get the approval of Product Specification File in alignment with the QP delegate in charge of the study. You also contribute to the review of regulatory files including R&D batches in the context of Partner authoring
In this role, you will...
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).
Prepare PSF following partner authoring templates and based on available source documents with the help of contributing Product Experts.
Coordinate the partner authoring review of the PSF.
Get the adequate approval(s) respecting the release timelines.
Ensure and engage for review and effective execution of the Regulatory Submission Building Process (RSBP) and act as liaison between TRD GMP/TRD GMP Quality and GRA for any regulatory related questions (including questions on Change Control/Deviation/PSF).
Support the release SME in the improvement of QMS standards and associated SOP's, following the gap analysis and related action plans.
In your area of responsibilities, ensure critical issues are adequately managed; ensure identification and characterization of the issue, impact evaluation on quality, safety and efficacy of GSK products and potential impact on clinical data as well on GSK business; ensure timely escalation to upper management including remediation plan proposals.
Why you?
Industrial Pharmacy degree, QP certification is a plus
Knowledge and/or experience in Quality Systems and Manufacturing process to facilitate the interaction between Manufacturing Operations and Regulatory in the preparation and maintenance of the Product specification File.
A good knowledge of pharmaceutical regulations is required to facilitate the understanding and assessment of technical issues and interactions with key stakeholders.
English and French are required
Apply now!
If this role fits your skills and ambition, we would love to hear from you.
Application closing date: Friday 04 September 2026
Please take a copy of the Job Description, as this will not be available post closure of the advert.
Skills
Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical Writing
Belgium Salary Range / Fourchette salariale – Belgique: EUR 55,425 to EUR 92,375The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.Le salaire de base mensuel brut minimum pour les nouvelles recrues à ce poste est indiqué ci dessus pour chaque lieu applicable. Ce salaire de base mensuel brut minimum tient compte de plusieurs facteurs, notamment les compétences, l’expérience et le niveau de formation du/de la candidat(e), ainsi que le taux du marché pour le poste. En outre, ce poste peut donner droit à un bonus annuel ainsi qu'une éligibilité pour participer à notre programme de long term incentive basé sur des actions, en fonction du niveau du rôle. Des informations plus détaillées sur l’ensemble du package salarial seront fournies au cours du processus de recrutement. Ce poste étant ouvert à des candidat(e)s basé(e)s dans plusieurs pays, des fourchettes de salaire sont également indiquées pour certains lieux. Les fourchettes salariales pour d'autres localisations sont mentionnées parce que certains marchés ont des lois en matière de transparence salariale qui imposent que les informations sur les salaires soient affichées dans les offres d’emploi, et que ces pays sont des lieux potentiels pour ce poste. Si aucune fourchette salariale n’est indiquée dans l’offre d’emploi pour un lieu ou un pays spécifique, la rémunération correspondante sera discutée au cours du processus de recrutement. Veuillez noter que les salaires varient selon le pays en fonction des compétences, de l'expérience, du niveau de formation du/de la candidat(e) et du taux du marché pour le poste. Les offres sont généralement faites dans la fourchette annoncée en fonction des compétences, de l'expérience et des qualifications du/de la candidat(e), la partie haute de la fourchette étant généralement réservée aux profils très expérimentés ou à des circonstances exceptionnelles répondant à ces critères.
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.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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