Clinical Labelling Compliance Lead
GSKa day ago
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HybridFull-time
Summary
GSK is seeking a Clinical Labelling Compliance Lead to join their Global Pack Management team in Zebulon, NC. The role involves overseeing clinical labelling content compliance for clinical supplies across R&D and ensuring adherence to global regulatory and quality standards.
About the Role
As a Clinical Labelling Compliance Lead, you will collaborate with clinical supply chain, packaging, IT technology, quality, and third-party teams. Your responsibilities include shaping processes, facilitating decision-making, supporting audits and inspections, and managing compliance processes across the Packaging, Labelling & Comparators (PLDC) group. You will also be accountable for managing third-party partners and responding to regulatory queries.
About You
Required:
- Degree or relevant experience in life sciences, pharmacy, regulatory, quality, or similar discipline.
- Demonstrated experience in clinical trial labelling, pharmaceutical labelling, or clinical trial supply operations.
- Expert in GMP for Clinical Trial Labelling and skilled in interpreting country regulations.
- Adept project and change management skills with strong attention to detail.
- Strong written and oral communication skills.
Preferred:
- Experience with global labelling systems or label management software.
- Experience with electronic label design tools and artwork control processes.
- Knowledge of clinical trial processes and investigational medicinal product (IMP) supply chain.
- Strong data literacy and experience using documentation and tracking systems.
Benefits
- Competitive salary with an annual bonus based on company performance.
- Healthcare and wellbeing programmes.
- Pension plan membership.
- Shares and savings programme.
- Hybrid working model for optimal work-life balance.
GSK
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Zebulon, NC