Senior Director, Clinical Supply Release

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership of QA disposition and the release of clinical supplies to support trial timelines while ensuring compliant and traceable execution.

• Ensure the completeness of batch and packaging records, readiness of labeling, and execution of release criteria for investigational products and clinical supply operations.

• Collaborate with Clinical Operations, CMC, Supply Chain, and external vendors to manage priorities and minimize release bottlenecks.

• Supervise deviations, investigations, and change controls that affect clinical release timelines, utilizing risk-based assessments and rigorous documentation.

• Maintain readiness for inspections by ensuring audit-ready clinical supply release documentation and governance.

• Manage release criteria, checklists, and documentation standards, driving consistent and compliant disposition decisions.

• Promote improvements in cycle time and right-first-time outcomes for clinical release workflows.

• Generate release checklists, release dashboards, and reports on clinical release cycle times.

• Ensure QA oversight during clinical packaging runs.

• Coordinate deviations, investigations, and change controls, ensuring prompt risk assessments and resolution of actions.

• Collaborate with Clinical Operations and Supply Chain on release schedules, priorities, and mitigation strategies.

• Create release risk summaries, issue/action logs, and escalation briefs.

• Maintain audit-ready release documentation and evidence packages to support GxP inspections.

• Oversee external clinical vendors as necessary and ensure compliance with labeling and packaging standards.

• Develop inspection-ready evidence indexes and vendor oversight packages.

⛳️ Requirements

• Bachelor's degree or higher in Science, Engineering, or a related discipline.

• Over 15 years of experience in GMP QA/release, with a strong emphasis on clinical supply experience.

• Exceptional documentation discipline.

• Excellent capability for cross-functional coordination.

• Willingness to travel 20–30% domestically and internationally.

• Experience in pharmaceutical or biotech clinical supply chains is preferred.

• Familiarity with IMP labeling/packaging is preferred.

• Experience with external clinical vendors is preferred.

• Background in supporting GxP inspections related to clinical supply release activities.

• Proficiency in Veeva Vault Quality (eQMS) for managing clinical release documentation and quality events that affect timelines.

• Knowledge of clinical supply release governance, batch/packaging record review, and decision-making for disposition.

• Understanding of cycle-time management, labeling/packaging readiness, controlled documentation, and quality of inspection-ready evidence.

• Experience in coordinating deviations, investigations, and change controls for clinical timelines.

• Ability to perform risk-based escalations and ensure action closure.

• Partner governance and performance management across external clinical vendors.

• Skills in cross-functional leadership, escalation, and executive-level risk/decision communication.

🏝️ Benefits

• Equity for all employees.

• Flexible paid time off.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Life/disability insurance.

• 401(k) traditional, Roth, and employer match offerings.

• Supplemental life insurance.

• Legal services.

• Mental health benefits through the Employee Assistance Program for employees and their families.

• Reasonable accommodations throughout the hiring process.