Director, Clinical Compliance

CSL

1d • Hybrid

About The Position

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re 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. Could you be our next Director, Clinical Compliance? The job is in our King of Prussia, PA or Maidenhead UK Office. This is a hybrid position and is onsite three days a week. You will report to the Head, of Clinical Compliance & Specialty Operations. You are responsible for leading a global clinical quality management and inspection readiness team. This role provides leadership and management for clinical compliance staff working to ensure that clinical study teams are following GCP practices. The position drives Quality by Design and risk-based approaches to study design and conduct in coordination with partners responsible for implementing and overseeing clinical trials. You will partner with Clinical Development Operations and Global Quality Assurance as needed during audits, regulatory inspections and other study assessment activities.

Requirements

• Degree (BSc/MSc/Diploma) in scientific/medical/pharmaceutical discipline is essential, preferably combined with relevant clinical trial experience.
• 10+ years of professional work experience in a Clinical Development/Research environment
• Extensive understanding of the clinical research and drug development lifecycle
• Experience in Compliance
• 3+ years of line management experience.
• Thorough knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directive

Responsibilities

• Develop the processes, systems and standards to enable inspection readiness of all clinical studies as well as ensuring compliance with quality standards. Manage internal quality processes in line with defined standards to ensure that quality is built in upfront and checks are appropriately integrated into study activities.
• Manage Inspection Readiness plan/processes across the portfolio to ensure inspection readiness for clinical trials at all times. Support Clinical QA during the regulatory inspection process to provide expertise regarding the Clinical Development Quality Management process.
• Drive the implementation of the Quality Management System (QMS) Framework in CSL Clinical Development Operations by ensuring a robust integration of all the QMS components and collaborating with Clinical Development functional areas to champion full compliance with new and existing regulatory standards and expectations.
• Lead the development of study level quality risk management plans for CSLB studies as required by the ICH GCP Guidelines by collaborating with Study Execution Team leads to identify, analyze and manage study risks that may impact the delivery of studies.
• Integrate Clinical Compliance Management (CCM) into Study Execution Teams (SET) to drive compliance checks, provide GCP guidance/consultancy and assist study teams identify/investigate quality issues.
• Lead Clinical Development approach to CAPA Management and ensure systematic investigation into critical/significant/systemic issues from all sources. Oversee and assist in the quality compliance (QC) and consistency checks of critical clinical documents to ensure compliance with ICH-GCP, internal policies/procedures, templates and formats required for regulatory filing and optimal clinical program/trial delivery.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees