Associate Director, Clinical Compliance

KPS Life is seeking an Associate Director of Clinical Compliance to work on assignment with one of our Sponsor partners. This role is required to work a hybrid schedule in Radnor, PA.

Main Purpose Of Job

The Associate Director, Compliance will work cross-functionally with Clinical Operations, Clinical Development, Clinical Compliance, Quality Assurance, Regulatory Affairs, Medical Affairs, and external partners to establish and maintain robust compliance frameworks that support our sBLA submission and subsequent regulatory inspections. This position requires a proactive, detail-oriented professional with deep expertise in Good Clinical Practice (GCP), regulatory compliance, and inspection preparedness within the biopharmaceutical industry.

Key Responsibilities

• Lead the development and implementation of comprehensive inspection readiness plans to prepare the organization for FDA pre-approval inspections related to the sBLA submission
• Organize mock inspections and gap assessments to identify potential compliance vulnerabilities and implement corrective actions prior to regulatory inspections
• Develop and maintain inspection readiness tools, including pre-inspection checklists, document repositories, and response protocols
• Coordinate inspection logistics, including identification and training of key personnel for critical support roles (e.g., scribes, document coordinators, subject matter experts)
• Oversee the development of comprehensive responses to inspection observations, including root cause analyses and corrective and preventive action (CAPA) plans
• Provide GCP compliance oversight for internal clinical operations processes and contracted external activities (CROs, clinical sites, vendors)
• Conduct compliance risk assessments to identify potential risks across Clinical Sciences activities and develop mitigation strategies
• Monitor compliance with regulatory requirements throughout the clinical trial lifecycle, from protocol development through study closeout
• Review and approve clinical study documentation for compliance with applicable regulations and company standards
• Collaborate with Quality Assurance to align compliance activities with broader quality management systems and ensure consistency in approach
• Work with Regulatory Affairs to support sBLA submission activities, including preparation of regulatory documentation and responses to health authority inquiries
• Build strong relationships with external partners (CROs, clinical sites, vendors) to ensure compliance expectations are clearly communicated and met
• Track and trend compliance metrics and audit findings to identify areas for improvement and measure effectiveness of initiatives
• Prepare regular compliance reports for senior leadership, highlighting key metrics, trends, and areas of concern
• Maintain current knowledge of evolving regulatory requirements and industry standards, providing updates and recommendations to leadership
  
  

Essential Qualifications

Education, Experience and Knowledge:

At least 10 years relevant, progressive experience in a biotechnology/pharmaceutical industry and/or clinical research organization with experience in compliance, quality, training, or related clinical operations function.

Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP.

Ensure an enthusiastic and open attitude towards continuous professional development

Experience with the following skill set:

• Inspection readiness assessments
• Presenting high level presentations, both orally and in writing using organizational skills to complement this
• Delivering open and honest constructive (positive and/or negative) feedback pertaining to work in hand
• Taking responsibility and ownership for entrusted tasks; seeing tasks through to completion and dealing with the consequences of failure or success.
• Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities. Handling disjointed tasks effectively. in a highly collaborative, multi-disciplinary team setting.
• Being able to work productively with others to achieve tasks while showing consideration for the needs and feelings of others.
• Accomplishing goals under project timelines.