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?

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