External Quality Small Molecule Americas Lead

GSK

22h•Hybrid

About The Position

This position is responsible for the Quality oversight of assigned Contract Manufacturing Organisations (CMOs) in an External Manufacturing specific Region to ensure MAH’s product quality, compliance and reputation is protected. This role will be accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned CMO(s) and with internal stakeholders. These include Procurement, Technical, Supplier Relationship, Regulatory, Business Development, Production, Site Management and other related GSK functions.

Requirements

Bachelor’s degree in science with experience in pharmaceutical manufacturing and quality operations.
Experience applying cGMP requirements and working with pharmaceutical analytical methods and manufacturing processes.
Experience in Technical Quality and Operational Quality roles within the pharmaceutical industry.
Experience with Lean six Sigma or operational excellence/lean manufacturing systems experience

Nice To Haves

Experience applying quality systems principles and quality/risk‑management tools.
Experience making data‑driven decisions using risk‑management methodologies.
Technical knowledge across multiple pharmaceutical dosage forms.
Experience performing statistical analysis and data trending.
Good communication skills, including preparing and delivering clear presentations, with proficiency in written and spoken English.
Effective stakeholder‑management and negotiation experience.
Strong problem‑solving capability and experience managing multiple priorities.
Experience partnering with external organizations and understanding commercial considerations.
Ability to anticipate issues, work under uncertainty, and manage evolving work demands.
Experience in interpreting and implementing cGMPs, regulatory guidelines, and industry standards within operational environments.
Experience in managing Change Management processes, including execution and documentation of quality‑related changes.
Experience in supporting workstreams that involve regional or global collaboration.
Project Management experience, including coordination of cross‑functional activities, timelines, and deliverables.
Bilingual in Spanish or Portuguese

Responsibilities

Lead Quality Agreement negotiations with CMOs and implement Quality Systems performance management, including KPI oversight per contractual requirements.
Ensure regulatory compliance by managing the flow of regulatory information between GSK and releasing sites as governed by Quality Agreements.
Monitor CMO quality performance, drive corrective actions, and assess KPIs (e.g., complaints, deviations) to identify continuous improvement opportunities. Apply risk‑management tools, escalate significant risks, and support RMS reporting to governance bodies (Quality Council, LIC, PIRC). Conduct purpose-driven GEMBA walks per the GEMBA Plan.
Partner with cross-functional teams (EM Procurement, PQTS+, Quality, Technical, Supply) to identify, communicate, and resolve quality or compliance risks to ensure consistent supply of quality products.
Collaborate with CMOs to ensure robust quality and manufacturing system outputs, including batch records, deviation investigations, change controls, validations, APRs, and product disposition. Provide GMP training where needed and review/disposition batch records when within EQ scope.
Drive periodic Quality Systems reviews at CMOs and support audits through GEMBA activities, root-cause analysis, and development of remediation actions.
Evaluate the effectiveness of CMO Quality Units and influence implementation of strong, self-sufficient quality systems. Escalate significant cGMP or compliance issues per internal procedures and support regulatory engagement and intelligence distribution.
Actively participate in External Manufacturing Quality Review Meetings, identifying issues and recommending continuous improvement actions.
Review and support responses to CMO regulatory inspections related to GSK products, assessing impact and suitability of responses prior to agency submission.
Work with suppliers to establish effective CAPAs tied to GSK audit observations, ensure timely closure, and coordinate Quality Alerts, Quality Plans, and continuous improvement activities. Support or lead internal audits as required.
Support technical and quality assessments for new product introductions, including review/approval of documentation (e.g., PTDs, PIFs) and defining quality requirements for tech transfers, validations, lab methods, stability protocols, SOPs, specs, and master batch records.
Support or execute timely disposition of finished product from CMOs to meet supply demands.
Where applicable, oversee quality relationships with third parties, manage medical device-related quality activities, release materials manufactured by CMOs, and lead/support GSK quality initiatives and projects.