Senior Manager, Clinical Compliance

Job Responsibilities

• Develop and execute a risk-based audit program covering internal processes and investigational sites; author audit plans and reports, and lead inspection readiness activities including TMF health assessments and mock inspections;
• Partner with Quality on audit scheduling, joint audit conduct, and preparation for regulatory agency inspections (FDA, EU Notified Body) and corporate quality audits.
• Serve as the central accountability point for CAPA status, effectiveness checks, and closure, coordinating with functional owners across sub-teams;
• Maintain alignment with Quality on CAPA creation, classification, and tracking to ensure consistency with enterprise quality system requirements.
• Own the vendor qualification and ongoing quality oversight program for CROs, core labs, EDC vendors, and other clinical service providers; issue and track SCARs, evaluate corrective action responses, and escalate unresolved quality issues with contract implications to leadership.
• Lead the Clinical Affairs procedure lifecycle, including authoring, reviewing, and approving SOPs and work instructions; coordinate the annual review cycle across sub-departments; maintain the controlled document management system in alignment with enterprise quality system standards, serving as the primary liaison to Quality on document control processes and procedure governance.
• Monitor and communicate regulatory developments and GCP guidance updates (FDA, ICH, EU CTR); evaluate impact on operations and procedures and serve as the department’s internal GCP compliance subject matter expert.
• Design and deliver the Clinical Affairs internal training program, including GCP onboarding, procedural updates, and audit corrective action training; maintain training matrices and completion records for all department personnel.
• Directly manage and develop the Specialist, Clinical Compliance; provide day-to-day direction, performance feedback, and professional development support.
• Support continuous process improvement and PMA/IDE activities as they relate to compliance, study conduct quality, and regulatory commitments; complete training for internal SOPs and maintain current regulatory knowledge.

Qualifications

• Required Education and Experience: 7+ years in clinical research, clinical operations, or clinical quality assurance; medical device experience strongly preferred. Minimum 3 years dedicated GCP audit or clinical compliance experience; demonstrated experience as a lead auditor conducting both site and vendor/CRO audits required. Bachelor’s degree or higher in life sciences, health sciences, or a related field required; advanced degree preferred. Thorough knowledge of ICH E6(R3), FDA regulations (21 CFR Parts 11, 50, 54, 56, 812), and ISO 14155; demonstrated SOP authorship and procedure lifecycle management experience. Prior people management experience; ability to lead and develop direct reports in a fast-paced, growing organization. Cardiovascular or structural heart therapeutic area experience is a significant advantage.
• Skills And Abilities Required For This Job: Lead auditor competency (planning, execution, report writing, finding classification); lead auditor certification (ASQ, RAPS, or equivalent) preferred. Experience with CAPA programs and risk-based quality management (RBQM); strong analytical and root cause analysis skills. Ability to influence without direct authority across clinical operations, data management, biostatistics, regulatory affairs, and medical affairs; proven cross-functional credibility. Excellent written and oral communication skills; able to produce clear audit reports, procedure documents, and executive compliance summaries; proficient in Microsoft Office Suite and eTMF/document management systems.