External Quality Drug Substance Lead (Person in Plant)

Site Name: Home Worker - KRPosted Date: Nov 6 2025Job PurposeThis individual will be the face of GSK quality at Contract Manufacturing Organisations (CMO’s), strategic suppliers and/or alliances. He/she will be accountable for implementing governance of and maintaining relationships based on transparency and trust. He/she will provide the on-site Quality and compliance oversight of production activities (bulk drug substance, analytical testing, drug product, packaging) in order to ensure GSK standards are met, to safeguard GSK’s patients, to protect GSK’s reputation, and to secure the external manufacturing large molecule clinical and commercial supply chains.ResponsibilitiesResponsible for building and maintaining direct Operational Quality oversight and management of relationships with CMO’s and external suppliers. This includes, but is not limited to record review and approval, authoring and executing quality agreements, implementing governance, audit support, etc. Leveraging a strong relationship built on trust and transparency, coach, mentor and influence suppliers to increase quality mindset and maturity to safeguard the GSK patients, the quality of our products, and our reputation. Facilitate decisions concerning the quality of material and subsequent disposition; escalate issues and risks that may have an impact on supply in a timely manner.Identify and lead continuous improvement initiatives to drive efficiency and eliminate waste.Ensure all quality issues are managed and communicated to GSK leadership in a timely manner; proactively identify and manage issues and risks to ensure business continuity; work to quickly investigate and resolve risks to the businessEnsure externally manufactured products are produced in compliance with registration details, GSK QMS requirements, and external manufacturing management processes. Where deviations occur, resolve, mitigate, or escalate to senior management as necessary.Work with partners to ensure on-time and in full/right-fist-time production, testing, and release of GSK products to meet supply chain demandCollate and review key performance indicators at the CMOAssist CMO with inspection preparedness planning including identification and development of storyboards, coaching, and identification of specific inspectional risks with a goal of continued inspection readiness.Support with product incidents where applicableReport and drive resolution of cGMP/Regulatory compliance issues. Request required legal documentation such as Certificate of Pharmaceutical Products (CPP), GMP certificate.Legalised and Notarised Declarations and documents as required by LOCs.Build and maintain good working relationships with internal partners, through compliance with applicable SOPs, Internal Quality Agreements and Service Level Agreement as applicable.Contribute to the evolution and implementation of GSK Quality Standards, the annual quality plan, and the overarching quality strategyEstablish and maintain regular dialog with team members, individually and collectively, providing feedback and recognition.Work across geographical time-zones if and when required to meet business needs.Will operate as part of a global PQTS (Procurement, Quality, Technical and Supply) model to support externally manufactured products.RequirementsDegree in Science or Engineering8+ years of experience in Manufacturing, QC, Engineering, Validation or Quality Operations) AND/OR equivalency in education and experience.7+ years of previous Biopharmaceuticals industry experience in technical or quality role(s) with at least 2 years of API, biopharmaceuticals or sterile manufacturing/or QC laboratory experience.Well-developed technical, quality and regulatory knowledge of current biopharmaceutical analytical and manufacturing techniques and processesSound understanding of quality systems and quality control processes3+ years of operational quality or compliance experience or other relevant experienceDemonstrated knowledge of GMP's, FDA, EU and other regulatory agencies (Japan, China etc) requirements with an ability to comply to quality and compliance.Demonstrated knowledge of quality system principles and practical applications.Demonstrated knowledge and ability to apply quality and risk management principles and tools.Demonstrated problem solving skillsStrong understanding of Data Integrity and ALOCOA+ principlesDemonstrated ability to make grade level decisions based on facts and data and application of risk management principlesExperience with work related travelExcellent written and oral communication skills -English.Strong influencing and negotiating skillsDemonstrated ability to develop staffCapable of managing across boundariesSolid knowledge of regulatory requirements including biological product and facility licensing requirementsProven ability to function independently, as a self-starter, and prioritize work.Thorough knowledge of cGMP's and ICH guidelines; demonstrated ability to implement these guidelines.Demonstrated sound decision-making skills.Demonstrated ability to lead work and collaborate within cross-functional teams (matrix management).Strong verbal, written communication and presentation skills.Solid understanding of Quality System principles and practical applicable, including emerging expertise in deviations/investigations/CAPA and Change Management.Demonstrated problem solving capabilities, with preference to direct experience in application of Deviation and Change Control Management, Human Factors Analysis.Prior CMO management experience desirable.Strong interpersonal and influencing skills.Demonstrated flexibility, ability to adapt and accommodate different/ multiple work demands.Strong understanding of current FDA/EMA validation practices including sterilization, cleaning, performance process qualification, shipping, computer systems, analytical methods.Solid understanding of drug development and manufacturing activities.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.Important notice to Employment businesses/ AgenciesGSK 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.