External Quality Small Molecule Americas Lead

Job Title:  External Quality Small Molecule Americas Lead

Job Purpose

This position is responsible is 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.

Key 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.

Why You:

Basic qualifications:

• 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

Preferred Qualifications:

• 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

Arrangements: 

The role is hybrid, requiring on-site work 2 to 3 days per week. Remote or fully home-working arrangements are not available for this role.

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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/