Posted Date: Apr 8 2025
Product Quality, Strategy Lead
Location: UK, Ware
Job Purpose
This role is responsible for the quality oversight of product (s) from the commit to phase III to commercial launch and through to product life cycle.
Key Responsibilities
Responsible for the quality oversight of the product or group of related products from PhIII through to commercial launch. Ensuring compliance with appropriate standards.
Accountable to ensure the quality management of changes, deviations and CAPA comply with cGMP standards.
Responsible for adhering quality milestones that will support acceleration from the commit to PhIII to product launch.
Product quality risk detection and ownership, overseeing actions and mitigation of the risk.
Responsible for reviewing the dossiers/ files submitted to health authorities.
Responsible for the approval of regulatory submissions and support in pre-approval inspection readiness.
Responsible for providing functional expertise and guidance to their assigned asset(s), communicating project needs to quality functional areas (e.g., external quality, quality assurance, lot release).
Responsible for quality element of the CMC matrix team in developing the overall product quality strategy.
Responsble for communicating / escalate of potential issues to line manager and manage through appropriate governance forum.
Management/ oversight of post approval changes .
Oversight of viral safety, sterility assurance and device controls for the aligned products.Review dossiers/files submitted to health authorities and approve regulatory submissions, supporting pre-approval inspection readiness.
Why You?
Basic Qualifications
Degree or equivalent in life sciences, or related sector.
Strong base experience working in pharmaceutical industry with understanding of GMP and standards required for clinical manufacture and release
Experience in quality assurance and quality control in an R&D or commercial environment is desirable.
Demonstrated ability to work across functions.
Clear communication style- both verbal and written
Job Application Close Date: 23rd April 2023
Please take a copy of the Job Description, as this will not be available post closure of the advert.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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