Clinical Labelling Compliance Lead

GSK

1d•Hybrid

About The Position

Clinical Labelling Compliance Lead Positioned in the Global Pack Management team, the successful candidate will oversee clinical labelling content compliance for clinical supplies across R&D, collaborating closely with clinical supply chain, packaging, IT technology, quality, and third-party teams to ensure labels adhere to global regulatory and quality standards. The role involves shaping processes, facilitating effective decision-making, and supporting audits and inspections. Additionally, this role will oversee linked-compliance processes across the Packaging, Labelling & Comparators (PLDC) group. We seek individuals who demonstrate strong risk-awareness and collaboration skills plus practical problem-solving ability and an improvement mindset. Join us to contribute meaningfully to the integrity of clinical studies while advancing your professional development in a global, science-driven environment.

Requirements

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 with associated experience supporting audits, inspections or regulatory submissions.
Expert in GMP for Clinical Trial Labelling, skilled in interpreting country regulations, understanding Quality Management Systems, and evaluating changes affecting PLDC with strong attention to detail.
Adept project and change management skills to ensure risk-based and compliant oversight of changes and deployment to teams.
Demonstrated ability to set and reach goals, high standards of performance and ability to resolve difficulties.
Able to apply third-party oversight, maintaining strong, fruitful, relationships whilst maintaining compliance.
Demonstrated proficiency with technology and can quickly achieve expert-level competence in key IT systems used in the design and creation of clinical trial labels.
Strong written and oral communication skills, confident in discussions with PLDC Leadership Team and able to collaborate well with others to achieve objectives.

Nice To Haves

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.

Responsibilities

Work with a third-party to identify and maintain industry and country-specific requirements within Clinical Trial Regulations and translate these requirements into compliant "Regulatory Rules” that will provide the content of our compliant Clinical Trial labels.
Identify, lead, assess and deploy changes to country label content rules via change management processes, engaging with appropriate stakeholders and documenting decisions and justifications such that they can withstand regulatory scrutiny. In doing so, you will become an SME in the IT systems used in the maintain and deploy label content.
Be accountable for management and oversight of GSK’s preferred third-party partner(s), owning, assigning and monitoring training requirements, maintaining relationship and upholding high quality standards.
Respond to queries and challenges from, amongst others, Regulatory Authorities on label content, and front label content topics in all internal and external audits, globally.
Own the risk management processes for the global PLDC team, chairing regular PLDC LT level meetings to identify, escalate and monitor tactical and strategic risks to ensure appropriate and compliant management of risk in PLDC.
Develop awareness of Quality Management System (QMS) updates that could impact PLDC, ensuring assessments are completed by appropriate SMEs and PLDC maintains compliance with the GSK QMS.