Are you energized by working in Product Quality? If so, this Product Quality Strategy, Senior Leader- SPQ role could be a great opportunity to explore.

As a Product Quality Strategy, Senior Leader- SPQ you will be responsible for the quality oversight of product (s) from the commit to phase III to commercial launch and through the product life cycle.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Drive the End-to-End Product Quality of commercial Vaccines or Medicines as competitive advantage focusing on proactive product, process, and analytical improvements.

• Lead Quality Strategy of New Products under late development (starting from phase III) to ensure that the overall Quality, Technical Development, Product Quality Risk, Compliance, and Regulatory considerations are integrated according to GSK Quality ambition and goals.

• Establish strategic partnerships with GSC Technical leads (MSAT Molecular Steward, Site Quality Heads, QC Heads), GSC Product Strategy team leads, GRA CMC leads, and RD CMC leads to ensure that Product Quality Strategy is embedded throughout development and commercialization efforts for successful launch, lifecycle management and continued marketing of GSK Vaccines and/or Medicines

• Chair the Product Quality/CMC Quality Team to ensure alignment on Quality Strategy of the assigned product and ensure One Voice Quality at CMC technical/strategy meetings

• Represent all Quality Functions at the PTLT/PSLT and responsible for defining the Product Quality Strategy team (PQSt) for commercial Vaccines or Medicines

• Responsible for Product Quality elements of the RD CMC matrix teams and developing the overall product quality strategy, including Quality oversight of TRA/CPP/PCS, definition of release specification, stability and Shelf-life strategy.

• Responsible for defining and adhering to CMC quality deliverables or milestones that will support NPI acceleration from the commit to Phase III to product launch

• Accountable to ensure the quality management of transversal/global changes, deviations and CAPAs associated with the assigned product comply with cGMP standards.

• Product quality risk detection and ownership, overseeing actions and mitigation of the risk.

• Quality oversight of Product Quality Reviews (PQR) and Manufacturing Robustness Review Boards (MRRB) for the assigned asset

• Responsible for reviewing the dossiers/ files submitted to health authorities.

• Responsible for the approval of regulatory submissions and support 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 communicating / escalation of potential issues and risks to line manager and manage through appropriate governance forum.

• Management/ oversight of post approval changes.

• Oversight of process validation, viral safety, sterility assurance and device controls for the aligned products.

• Accountable to ensure compliance with all training requirements assigned on time

• Ensure compliance with cGMP, GSK policies and procedures as required and if applicable.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's Degree in a Science discipline such as chemistry

• 7+ years working in pharmaceutical industry with GMP and CMC Quality standards required for clinical and commercial manufacture

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master's Degree in Analytical Chemistry, Biochemistry or similar.

• 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.

• Sound and timely decision-making and problem-solving skills

• Able to work in matrix teams and leading matrix teams

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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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