Senior Director, Head of Clinical Compliance & Speciality Operations

New Yesterday

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. TheHead of Clinical Compliance and Specialty Operationsis a senior leadership role responsible for ensuring that clinical development activities are conducted in full compliance with global regulatory requirements, internal policies, and Good Clinical Practice (GCP) standards. This role also provides strategic and operational oversight for specialized clinical operations functions, including clinical lab sample management, TMF operations, and the execution of studies via full-service outsourcing (FSO) models.
Clinical Compliance Leadership Lead the development, implementation, and continuous improvement of the clinical compliance framework across all therapeutic areas.
Serve as the primary point of contact for inspection readiness and regulatory audits.
Partner with Quality Assurance and Clinical Operations to identify, assess, and mitigate compliance risks.
Ensure harmonization of compliance practices across global teams and integration of acquired entities or business units.
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Location:
Maidenhead
Salary:
not provided
Job Type:
FullTime
Category:
Admin, Office, Secretarial & PA

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