External Quality Drug Product Lead

Role Overview As an External Quality Drug Product Lead, you will be reporting to the Specialty External Manufacturing Quality Director or deputy. This role supports the Biopharm Supply Chain products that are externally manufactured and tested to ensure products comply with GSK Quality expectations, specifications, and registered details. You provide quality and regulatory support to ensure clinical/commercial manufacturing, new product introductions, and transfers at external suppliers provide a timely and reliable supply of quality products. Responsibilities Support implementation and continuous improvement of quality processes and procedures required to ensure GMP expectations for GSK external suppliers are met. Build and maintain trusting relationships with external partners to influence and assure GSK quality standards are met. Support collection, monitoring, and analysis of quality performance indicators of external suppliers using quality standards and tools to identify and promote emerging or developing trends. Partner with key contacts at the external supplier to ensure that outcomes from quality and manufacturing systems—such as batch records, deviation investigations, change controls, validations, annual product reviews, and product disposition—are robust and ensure product quality. Support quality and regulatory compliance, including compliance with QMS and cGMP requirements of external suppliers through the GMP audit process. Support risk identification and mitigation processes of external suppliers and escalate as necessary. Assist external suppliers with inspection preparedness planning, including identification and development of storyboards. Report and support resolution of cGMP and regulatory compliance issues, and request required legal documentation such as Certificate of Pharmaceutical Products, GMP certificates, and other documents as required. Build and maintain good working relationships with internal partners by complying with applicable SOPs, technical terms of supply, and service level agreements. Seek clarification on roles and responsibilities to ensure team alignment, and complete role‑based training as assigned. Communicate on an ongoing basis with Quality Managers and Directors to ensure that potential quality issues are identified and addressed with an appropriate sense of urgency. Basic Qualifications Bachelor's degree in pharmacy, science, or an engineering discipline. 5+ years of manufacturing or quality experience in the pharmaceutical industry. Experience with the application of quality systems in manufacturing, warehousing, and distribution. Preferred Qualifications Master's degree in a science‑related field. Ability to communicate and engage internal and external stakeholders. Ability to work independently and prioritize workload. Strong interpersonal skills with an ability to enable and drive change. Problem identification and solving skills. Experience working with multi‑functional teams. Equal Opportunity Employer Statement 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. #J-18808-Ljbffr GlaxoSmithKline