Description
We are seeking an Expert Standards LMSAT to join our team in Quebec, Canada. As an Expert Standards LMSAT, you will play a technical expertise role to ensure the mastery and effective implementation of LMSAT technical standards on the site.
The successful candidate will act as a technical reference for one or more LMSAT standards, including:
- Product and process lifecycle (PLM, steps 1 to 3)
- Cleaning validation
- Contamination control, including microbial contamination, physical particles (PCCE), and extractable and leachable substances (E&L)
- Visual inspection
- Single-use systems (SUS)
Your main responsibilities will include:
- Acting as a technical reference on the site for one or more LMSAT standards
- Providing expertise and technical support to site teams
- Strengthening site capabilities and knowledge in LMSAT technical standards areas
- Contributing to the definition, evolution, and implementation of GSC technical standards
- Participating in communities of practice, working groups, and continuous improvement initiatives
- Defining and supporting the implementation of appropriate governance on the site
- Developing and tracking performance indicators (KPIs) to measure standards implementation effectiveness
- Identifying and escalating issues or difficulties encountered in applying standards
- Collaborating with global LMSAT standards owners and site experts
- Maintaining up-to-date knowledge of regulatory requirements, inspection expectations, industry standards, new technologies, and risks
To be successful in this role, you will need:
- A university degree in a scientific, technical, or engineering discipline
- At least 5 years of professional experience in a relevant technical domain
- Experience in one or more of the following areas: cleaning validation, process validation lifecycle (steps 1 to 3), contamination control, visual inspection, single-use systems (SUS)
- Experience working in multidisciplinary teams and matrix environments
- Knowledge of risk management and project management
- Good understanding of applicable regulatory requirements
- Excellent technical writing and communication skills
- Ability to influence, collaborate, and work effectively with stakeholders at different organizational levels
- Autonomy, proactivity, and a positive and constructive attitude
- Ability to manage multiple priorities, organize work, and meet deadlines
- Advanced English language skills, both written and verbal
The successful candidate will be based in Sainte-Foy, Quebec, with regular presence on-site and in the field to collaborate with teams, support technical activities, and participate in meetings, validations, and other activities requiring on-site presence.
In this role, success will be measured by:
- Effective understanding, adoption, and application of LMSAT technical standards on the site
- Teams having necessary support and expertise to apply standards consistently
- Issues related to standards implementation being identified quickly and tracked appropriately
- Best practices being shared effectively between the site, other GSK sites, and global experts
- Performance indicators enabling progress measurement and continuous improvement
- Initiatives and projects related to LMSAT standards being completed in accordance with quality, regulatory, and operational requirements