This role is responsible for facilitating the delivery of Quality Management activities related to Clinical Operations within R&D, working with partners across the business to embed quality/compliant practices, and leading and guiding proactive inspection readiness activities.

Key responsibilities include establishing and maintaining effective systems and processes to support key performance areas for the function & wider organisation to maintain Quality Management excellence, working closely with colleagues and collaborators to support quality assurance and regulatory adherence initiatives, promoting a culture of quality across R&D as a quality champion, and providing advice and standard process guidance on GCP or other relevant regulatory standards.

Additional responsibilities include providing support to collaborators to ensure appropriate root cause analysis is conducted and CAPA plans are defined, assisting business function(s) with CAPA effectiveness checks, assisting assigned partners and collaborators as they prepare for regulatory inspections, supporting identification and management of quality risks, including mitigation of risks and communication of significant risks to management, and assisting with relevant quality related communications and customer concerns.

The ideal candidate will have a Bachelor's degree in a related discipline, preferably in life science, and a higher degree in a scientific or business discipline is desirable. They should have 4+ years of in-depth proven experience in a clinical compliance or quality related position with a track record of success in leading quality and compliance activities.

Knowledge of current GCP guidelines and regulations, including ICH guidance and other regulatory requirements, is essential. Proven project management skills are also required.

The annual base pay for this position ranges from $137,344.80 - $206,017.20 USD.

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