Overview Site Name: Belgium-Rixensart, Italy - Siena
Posted Date: Feb 4 2026
Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D
Position Summary
The Quality Control Release & Stability Testing Director is accountable for end‑to‑end oversight of QC release and stability testing activities for clinical products. This leader will define strategy, build and lead high‑performing teams, drive technical and regulatory excellence, and partner across functions to ensure timely, compliant product release and a robust stability program that supports product development, lifecycle management and continuous improvement.
Responsibilities Leadership
Work closely with analytical development on qualification and validation activities for release and stability methods, including stability‑indicating assays. Champion method lifecycle management: suitability assessments, transfer strategies, troubleshooting, robustness testing and periodic review.
Develop and report on KPIs and performance metrics (e.g., release turnaround time, assay performance, stability trends, deviation rates), and present insights and remediation plans to executive leadership.
Lead SOP authoring frameworks for release and stability activities, ensuring standardized documentation, change control and inspection readiness.
Guide complex investigations related to out‑of‑specification (OOS) and out‑of‑trend (OOT) events, authoring scientific justifications and remediation plans with cross‑functional input.
Build, lead and retain a high‑performing QC release and stability testing organization, including laboratory managers, scientists, stability coordinators and data specialists.
Establish competency frameworks, deliver GMP and technical training programs, and certify staff to perform critical release and stability tasks. Develop succession plans and career development pathways; mentor leaders to drive accountability and continuous improvement.
Operational Management
Oversee daily operations of sample receipt, chain of custody, analytical testing, data review, work closely with analytical operation and QA for batch disposition and release notifications, ensuring on‑time and compliant releases.
Manage the stability testing program lifecycle: protocol design, sample allocation, timepoint management, trend analysis, shelf‑life proposals and stability reporting to support regulatory submissions and CMC lifecycle activities.
Ensure robust material and reference standard management practices, including qualification, storage, calibration and reconciliation across sites and partners.
Optimize laboratory throughput and capacity planning, applying lean principles and automation where appropriate to improve efficiency and reduce cycle times.
Quality Systems and Compliance
Maintain and continually improve QC quality systems including SOPs, deviations, CAPA, investigations, change control and training to meet GMP and other regulatory requirements.
Lead audit and inspection readiness activities for internal and external audits, ensuring evidence packages are comprehensive and that corrective actions are effective and timely.
Promote a culture of data integrity and compliance, ensuring appropriate segregation of duties, independent data review and electronic records management.
Cross‑Functional Collaboration and External Partnerships
Serve as the primary QC release and stability interface to manufacturing, process development, clinical operations, CMC regulatory leads, supply chain and external partners.
Lead coordination of cross‑site and partner activities for sample exchanges, cold chain logistics, reference material lifecycle and clinical product dispositioning.
Work closely with IT and data analytics teams to implement dashboards, automate reporting and enable real‑time monitoring of release and stability metrics.
Implement risk‑based testing strategies and prioritize resources to focus on critical quality attributes and high‑risk assays.
Lead continuous improvement initiatives (e.g., automation, digital tools, assay consolidation, throughput improvements) to reduce variability, shorten timelines and lower cost of goods.
What you will need Basic Qualification
Degree in chemistry, analytical chemistry, pharmaceutical science, or related scientific discipline (BSc, MSc or equivalent).
Relevant pharmaceutical industry experience, with progressive responsibility in QC release or stability testing.
Experience with analytical method validation, transfer and troubleshooting (HPLC/UPLC, GC, dissolution, spectroscopic techniques, or equivalent).
Preferred Qualification
Advanced degree (MSc or PhD) in analytical chemistry or related field.
Experience with stability program design for multiple dosage forms and lifecycle management.
Experience with regulatory submissions and responses related to QC data.
Hands-on experience with laboratory information management systems (LIMS) and electronic records.
Track record of implementing process improvements, risk-based approaches and analytical trend analysis.
Experience working with cross-functional CMC, manufacturing and external partners in a matrix environment.
Experience managing laboratory teams, vendors or contract testing partners.
Strong knowledge of GMP, data integrity principles and regulatory expectations for release and stability testing.
Excellent communication skills in English; knowledge of local languages is an advantage.
What we offer in this role You will lead activities that directly affect patient safety and product quality. You will have the chance to shape processes and grow a team that delivers reliable science. You will work with talented colleagues across functions and external partners. We encourage continuous learning and provide opportunities to develop leadership and technical skills.
Location and working model This role is based in Belgium or Italy. This is a hybrid role
The role is on-site. Hybrid working arrangements may be discussed during recruitment, but regular on-site presence is required to lead laboratory operations.
Apply now If you are motivated to lead QC release and stability testing with impact, we want to hear from you. Please submit your CV and a brief note describing how your experience fits this role and why you are interested. We welcome candidates from all backgrounds and are committed to inclusion in our workplace.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
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.
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