Director, GCP Quality Inspection Management

Overview

The Director of Inspection Management/Quality Compliance will report to the VP and Head of Global Quality. The Director, GCP/GVP QA, leads the end-to-end GCP/GVP QA strategy, compliance, and inspection readiness program across the organization. The role oversees a GCP QA team, drives risk-based audits and quality-by-design integration, and manages quality risk processes, metrics, and compliance oversight for GCP and GVP activities.

Key compliance responsibilities include monitoring adherence to GCP/GVP regulations, company SOPs, and ICH guidelines; assessing and reporting compliance status across functions; and ensuring timely remediation of findings from audits and inspections. The Director also maintains regulatory intelligence to anticipate changes in global requirements and translates them into actionable QA and compliance standards. Additional responsibilities include leading inspection readiness internally and at clinical sites with CROs, conducting mock inspections and audits with Compliance QA, and acting as the primary moderator for regulatory sponsor inspections.

The Director partners with Clinical Development, Operations, Regulatory Affairs, Patient Safety, Data Management, Biostatistics, and external partners to resolve issues and drive continuous improvement. This role aligns QA and compliance strategy with business and regulatory goals, serves as the primary QA point of contact for stakeholders, and ensures clear communication, transparency, and a unified "One Voice for Quality" across the organization.

• Establish and maintain the GCP/GVP Inspection Readiness program and support the development and revision of functional and cross-functional policies and procedures; support auditing and compliance monitoring of non-clinical and clinical trials in accordance with applicable health authority regulations and guidelines.
• Responsible for the overall health of the GCP/GVP Inspection Readiness program, risks anding with cross‑functional stakeholders to identify GCP/GVP issues and risks, and creating a risk log and an overall scorecard that can be applied to manage and mitigate risks.
• Develop QA GCP/GVP strategy for a team within QA with clear goals and objectives that align with business needs; manage complex issues leveraging benchmarking data and experience, escalates rapidly when needed, and drives resolution.
• Partner with Compliance Clinical Operations for Clinical Site Audits; use the outcomes to inform risk‑based decisions and development or refinement of metrics designed to identify potential noncompliance at SK‑sponsored clinical trial sites.
• Assess new regulations and guidance to determine if any changes need to be made to internal GCP and GVP processes and/or if any training needs to be developed and delivered.
• Oversee and coach GCP/GVP QA team members through regular individual touchpoints and team meetings.
• Develop a GCP/GVP QA playbook that incorporates past experiences and challenges to train team members to identify common clinical trial issues, such as protocol deviations or potential serious breaches, that could impact patient safety and/or data reliability.
• Serve as a GCP/GVP change management agent, establishing and maintaining a culture of quality and compliance.
• Review and approve, as applicable, non‑clinical and clinical trial documents, including clinical study protocols and amendments, risk management plans, etc., and regulatory agency submissions, as applicable.
• Partner with key stakeholders, including Clinical Operations, Data Management, Safety, other cross‑functional teams, and QA oversight of the CROs and other critical vendors.
• In partnership with functional stakeholders, identify and manage issues and risks, making sure to document such issues and risks in a risk log so that risk assessment activities are captured, and awareness of key risks is properly disclosed to the relevant parties.
• Interpret and apply ICH E6 (R3), Good Clinical Practice (GCP) ICH regulatory guidelines and directives for clinical trials involving human subjects, in line with the goals and principles of ethics in clinical trials, compliance with the study protocol,…