Director, R&D Audit Program - It Systems

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

• Drive for a state of inspection readiness across R&D for GxP relevant IT Systems, related vendors and service providers
• Lead intra or interdepartmental teams such as improvement initiatives
• Train and manage internal staff
• Foster a commitment to quality and a culture of quality within the organization
• Generate audit reports and communicate observations to relevant parties
• Provide guidance on GxP and relevant IT regulations for internal stakeholders
• Approve audit responses and ensure execution of corrective and preventive actions
• Cultivate and maintain strategic relationships and collaborations both internally and externally
• Conduct audits according to approved audit execution plans
• Perform risk assessments for GxP relevant IT Systems, related vendors and service providers across R&D
• Support overall R&D Quality & Medical Governance goals
• Develop detailed audit execution plans
• Using a risk-based approach, lead the development of the annual R&D audit plan for GxP relevant IT Systems, related vendors and service providers
• Execute against the annual audit plan with the orchestration of internal and external auditors
  • Develop detailed audit execution plans
  • Conduct audits according to approved audit execution plans
  • Generate audit reports and communicate observations to relevant parties
  • Approve audit responses and ensure execution of corrective and preventive actions
• Identify and communicate trends for robust mitigation
• Provide metrics for effective reporting of audit observations

• Significant experience leading cross functional projects and teams
• Ability to travel approximately 20-30% required.
• Expert knowledge with 21 CFR Part 11 electronic systems and compliance
• 12+ Years with BA/BS or 10+ Years with MA/MS/MBA or 8+ Years with PharmD/PhD
• Experience in implementing principles for Quality Risk Management
• Excellent organizational and project management skills
• Strong verbal and written communication skills and interpersonal skills
• Extensive experience leading GxP IT System audits in R&D in the biopharma industry

The salary range for this position is: $199,835.00 - $258,610.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.