Senior Director, R&D GxP Audit

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

📋 Description

• Direct the global strategy, implementation, and ongoing enhancement of the audit program for both internal and external processes that supports the Research & Development (R&D) Quality organization.

• Deliver independent assurance that systems, processes, vendors, and clinical trial operations adhere to relevant GxP regulations, internal standards, and industry norms.

• Manage risk-focused audit programs encompassing GCP, GLP, Pharmacovigilance, computerized systems, data integrity, and vendor management.

• Collaborate closely with R&D Quality leadership, Global Development, Safety, Regulatory Affairs, and external stakeholders to bolster compliance, readiness for inspections, and proactive risk management.

• Design and implement a global, risk-oriented GxP audit strategy that aligns with quality and portfolio priorities.

• Establish and lead a high-performing audit team.

⛳️ Requirements

• Doctorate degree coupled with 5 years of experience in Quality Assurance or Strategy within a regulated industry OR a Master’s degree with 9 years of experience in Quality Assurance or Strategy within a regulated industry OR a Bachelor’s degree with 11 years of experience in Quality Assurance or Strategy within a regulated industry.

• Minimum of 5 years of experience in directly managing personnel and/or experience in leading teams, projects, programs, or directing resource allocation.

• Advanced degree (MBA, MS in Operations/Engineering, or similar).

• Extensive knowledge of GxP regulations, including GCP, GLP, GVP/PV, and quality systems.

• Proven track record of successfully leading intricate internal and external audit programs.

• Strong understanding of risk management, CAPA systems, supplier oversight, and readiness for inspections.

• Exceptional executive communication and influencing capabilities.

🏝️ Benefits

• A comprehensive employee benefits package, which includes a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.