Quality R&D Third Party Senior Lead

Are you energized by a highly impactful quality role that drives process improvement and broad stakeholder engagement? If so, this Quality R&D Third Party Senior Lead opening could be an ideal opportunity to explore.

As a Quality R&D Third Party Senior Lead, you will be responsible for designing, developing and implementing Third-Party Quality strategies and quality oversight for external GMP services provided to GSK R&D to ensure that GSK external providers of critical services (CMOs) comply with GSK data integrity and quality standards, GxP regulations and meet national health authority requirements. Promote and implement a Quality and Safety culture within GSK R&D. Provide GSK business owners and third parties with GMP expertise and regulatory compliance advisory and act as a valuable source to GSK R&D (MDS, GH, and Vx TRD) for the selection of GMP suppliers for vaccine R&D projects allocated, while promoting operational efficiency, continuous improvement and contributing to R&D pipeline acceleration.

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

• Responsible for the design, development, and deployment of Quality strategies, policies, group objectives and processes for GMP third parties supporting R&D projects, including for externalized process/product developments outsourced to CDMOs.

• Drive and support the business by implementing end-to-end quality oversight of GMP third parties in scope:

• Make the initial technical assessment of external providers, utilizing Quality Questionnaires, assess third parties (gap analysis) and drive decision-making with the remediation plan and level of audit/assessment required (quality risk management)
• Lead, negotiate, review and implement Quality Clauses/Agreements with business partners and third parties in scope and/or across R&D, to ensure compliance with current regulations, GSK quality standards associated with the activities to be carried out by the third party.
• As relevant, allow that all information/documentation (procedures - submission documentation...) be transferred to the Third Party, and act as a trainer if requested by the R&D Business Owner
• Ensure that the Third-Party qualification is completed before the contract becomes effective and GMP operations start
• Risk Management: Support and assist in risk areas identification, escalation, and mitigation plan development.
• Evaluate, follow up, trend, give feedback, and approve the deviations generated during activities according to the quality agreement/contract requirements.
• Ensure CAPA implementation and closure accountability, following regulatory inspections and GSK audits.
• Evaluate and follow up on change controls generated by the Third Party and escalate as needed.
• Ensure Quality Systems at Third Party site are in line with GSK expectations, through appropriate oversight and efficient analysis tools.
• Investigate major/critical deviations, issues, or technical complaints within the time frame defined. Identify and mitigate critical/major issues that could impair the performance of the activities.
• Track, analyze, and communicate metrics to ensure efforts are implemented effectively and in line with quality goals, strategy, and objectives. Identify improvement opportunities.
• Lead and perform a periodic Risk assessment regarding the Third Party, he/she is responsible for.
• Identify, assess and mitigate quality risks adequately. Develop and maintain the in-scope audit universe and propose a fit-for-purpose strategy for the yearly TP audit planning, per business needs and requirements.
• Ensure proper archiving of quality records documentation to guarantee traceability during the required retention period, by procedure, as relevant

• Interface with R&D Procurement, Legal, Auditing Teams, and business partners to ensure internal GSK alignment on third party quality oversight, while remaining independent in his/her quality evaluation role. Interact with the Technical Development Lead/CMC Lead and PQL's to ensure all product and process-related issues are properly addressed at the Third Party.

• Manage quality meetings (timeframe to be defined) according to a pre-defined agenda to review the quality performance, ensure highlights are captured and drive continuous quality improvement plan. Represent the Third-Party Quality team within various meetings, governances, and report points and issues within the defined timelines.

• Review and approve all the required documentation for the batch release process.

• Support audit-readiness status maintenance, preparation, conduct, and follow-up for Audit & Inspection activities, when appropriate, in direct interaction with the R&D audit team.

• Escalate, manage and support issues management. Engage with third parties on operational issues (e.g. process deviations, out-of-specifications QC results) that require an investigation by the vendor, to fully assess Product Quality impact and inform batch(es) usage decision.

• Contribute to the development, improvement & simplification of standards and processes across the R&D Third Party Quality department.

• Remain current with industry trends and changes in the regulatory and external environment through established networks - to ensure that any issues likely to impact the Third-Party network are well understood and communicated to avoid disruption to services.

• Promote partnering with peers and strong interactions with Commercial External Manufacturing teams and across R&D, and utilize its expertise to influence, simplify and provide insightful analysis to align ways of working and achieve improvement of common processes and help the R&D Quality department to optimize oversight and risk assessment of Third Parties.

Basic Qualifications:

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

• Bachelor's Degree & 7+ years of pharmaceutical industry

• Experience in at least one of the areas of Quality Assurance/Operations OR Production OR Engineering

• Experience with current Good Manufacturing Practices (GMPs)

• Experience with on-site manufacturing or with external manufacturing parties

Preferred Qualifications:

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

• Master's degree or PhD

• Previous assignment experience promoting a regional or global perspective

• Project Management skills and leadership skills

• Operational Excellence experience

• Experience with Quality and Risk Management principles and tools

#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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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).

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