Job Purpose
The job owner has a GSME role in Extractables & Leachables.
The job owner acts as primary GSME support for Medicines Large Molecules & Vaccines division including related CMOs.
The job owner aligns the E&L GSC strategy with R&D, who are accountable for new product development and commercialization, aiming for a smooth transfer of commercial products.
The job owner will conduct and document E&L risk assessments for biopharmaceutical manufacturing processes, container closure systems and dosing device (an interim until LSME network in Medicines Large Molecules division is in place and in use.)
The job owner has the task to create and/or update the relevant internal standards (GQP, GQSOP, GG etc.) related to E&L strategy deployed in GSC.
The job owner benchmarks internally and externally in the domain of expertise.
The job owner will advocate GSK E&L position externally through international working groups (A3P, ISPE, BPOG,…) and/or conferences.
The job owner manages risks escalation to the different parts of GSK.
This job aims at providing expertise and supporting the GSK network.
The job owner must deliver key technical information to business partners, to support business decisions and/or regulatory filings.
The job owner will work with internal and external laboratories to ensure E&L testing is delivered in a scientific, compliant and cost effective manner.
The job owner will participate to MSA process of GPROC to set up technical agreements and technical audits with potential E&L lab suppliers.
The job owner will interact directly with regulatory agencies during audits to present E&L GSK strategic topics.
The job owner acts as key contact person for Quality Regulatory Intelligence activities.
The job owner defines the expertise’s lifecycle strategy.
The job owner establishes the expertise’s lifecycle strategy.
Key Responsibilities
Expertise / Technical Knowledge
Monitor and assess new developments, industry trends, evolving regulatory expectations in area of expertise
Represent GSK in internal and external boards and contribute to the development of new standards
Maintain current knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, innovative / new technologies, industry standards and registered risks pertaining to area of expertise
Define GSK requirements and sets policies and standards which are implemented through QMS, GQSOPs, technical standards or other means (e.g. assess requirements and propose global/local actions to avoid re-occurrence)
Ensure compliance with external and internal requirements (e.g. GSK QMS, GSK GQSOPs) through interaction with internal organization
Support sites in implementation of GSK requirements
Lead or Support projects and other activities (e.g. ownership of transversal risks) in Quality and GSC, partnerships and Joint Ventures
Provide expertise support (e.g. inspections preparation and response writing, risks, observations, deviations, improvement initiatives, remediation, Quality Alerts)
Network Management
Be part of GSK E&L experts team
Develop mid / long term vision and strategy within network
Support sites to assess need for escalation to relevant Quality Council (if issue is applicable to other sites)
Share global learnings through CoP
Process Ownership
Accountable to drive global strategy in area of expertise
Define GSK system / process mandatory standards in compliance with GSK QMS requirements
Deploy process throughout network and ensure standardization/harmonization at the appropriate level
Drive continuous improvement
Own and maintain applicable global procedure (e.g. GQSOPs), tools, templates, and other documents
Own applicable libraires, repositories etc.
Deploy digitalization in his/her field of expertise
Basic Qualifications
At least 4+ years of working experience required in one of the following: E&L, Validation
Risk Management
Regulatory knowledge related to the specific expertise
Strong technical writing skills
Benchmarking skills
EHS-awareness
Proficient in both written and spoken English
Preferred Qualifications
Strong interpersonal and communication skills
Demonstrated ability to work effectively across a diverse customer base
Awareness of FDA, US Pharma and Good Manufacturing Practices (GMP) requirements related to packaging
Ability to work effectively in a matrix organization across geographies and cultures
Teamwork ability
Networking and facilitation skills
Coaching, mentoring, training
Problem solving attitude
Can-do spirit
Customer focus
Able to propose solutions in critical situations
Prioritization skills
Execution & coordination skills in validation
Supplier interface
Belgium Salary Range / Fourchette salariale – Belgique: EUR 71,400 to EUR 119,000
The 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.
La fourchette de salaire brut de base annuel pour les nouveaux travailleurs dans ce rôle est indiquée ci-dessus pour chaque localisation concernée. Ces fourchettes tiennent compte de plusieurs facteurs, notamment les compétences du/de la candidat(e), son expérience et niveau de formation, et le taux du marché pour ce type de fonction.
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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