Oakley is a quality and regulatory affairs leader with over 20 years of experience across both CRO and sponsor organizations, overseeing GCP quality systems, global audit and inspection programs, and regulatory strategy for international clinical trials. Her career spans collaborations with emerging biotechs through to more established sponsors, supporting development programs from early phase through submission.

She brings extensive experience working with the FDA, EMA, MHRA, and other global regulatory authorities, guiding sponsors through complex regulatory landscapes with clarity and foresight. Known for building pragmatic, risk-based Quality Management Systems, Oakley ensures that innovation and operational agility are fully aligned with inspection-readiness and compliance expectations.

Her expertise includes GCP quality assurance frameworks—encompassing SOP development, CAPA management, risk-based quality management, and vendor oversight—as well as leading global audit programs across investigator sites, vendors, and internal functions. She has also supported clinical trial applications (CTA/IND), amendments, and the clinical components of NDA and MAA submissions.

Passionate about embedding quality by design across the study lifecycle, Oakley works in close partnership with clinical operations, biometrics, and pharmacovigilance teams to proactively identify risk and strengthen delivery. Her collaborative leadership style and regulatory insight provide small and mid-size biotechs with the confidence that their programs are not only innovative, but fully inspection-ready at every stage.