Director, Qc Release and Stability Testing

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**Site Name**: Belgium-Rixensart, Italy - Siena
**Posted Date**: Feb 2 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.
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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. Key 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. **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. Why You? Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals: - Degree in chemistry, analytical chemistry, pharmaceutical science, or related scientific discipline (BSc, MSc or equivalent).
- Relevant pharmaceutical industry

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