Executive Director, Global Head of Inspection Management

Gilead Sciences • Foster City, CA

308d • $255,425 - $330,550

About The Position

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfill their aspirations. Join Gilead and help create possible, together.

Requirements

• BS/BA degree in Biology, Sciences, or related discipline and a minimum of fifteen years of related experience; or, MS/MA degree in Biology, Sciences, or related discipline and a minimum of thirteen years of related experience; or, PhD in related discipline and a minimum of twelve years of related experience; or, Equivalent combination of education and experience.
• Experience in the biotech or pharmaceutical industry is required.
• Experience in managing Health Authorities during inspection.
• Experience in managing Customer/Business Partners during inspection.
• Experience in a regulatory authority is highly desirable.

Nice To Haves

• Applies wide ranging knowledge of biotechnology/pharmaceutical sector to perform complex work, demonstrate influence beyond the QA function and make decisions on complex issues.
• Demonstrates strong organizational and planning ability to creatively analyze and improve processes and set standards for high quality work.
• Establishes high performance standards and clear responsibilities to prioritize and complete multiple activities within established timelines.
• Demonstrates authoritative, effective, and adaptable communication skills in a range of media; promotes engagement to facilitate critical discussions.
• Fosters collaboration amongst teams and wider stakeholders, to gain mutual trust, achieve alignment and deliver on common goals.
• Models team spirit, culture, and ethics, builds high-performing teams to meet company objectives.

Responsibilities

• Accountable for managing globally the implementation, maintenance, and execution of the Gilead Inspection Readiness program, including the creation of an inspection readiness scorecard across all GxP functions in PDM.
• Accountable for Inspection Management activities globally, including setting the strategic plan for maintaining organizational inspection readiness across Gilead's products in all stages of development or commercialization.
• Directs maintenance of inspection opening presentation materials to ensure consistency and currency.
• Supports internal logistics during Inspections and mock inspections of Gilead and CDMO/CTLs.
• Oversees the provision of inspection related training.
• Performs mock sessions to ensure readiness for health authority inspections.
• Partners with other groups, including Regulatory Affairs, Clinical, Safety, Commercial, Supply Chain, Quality Control, MSAT regarding compliance assessments and provide compliance guidance related to GxP processes.
• Responsible for ensuring Gilead stays abreast of current regulatory requirements, informing stakeholders of the potential impact on the organization or related systems, and initiating gap assessments with stakeholders (as necessary).
• Represents Inspection Management in internal/external presentations on quality issues, initiatives, and projects regarding audit or inspection readiness processes.
• Responsible for developing, tracking, and reporting compliance and inspection metrics and communicating trends or significant findings to executive management.
• Assesses proposed corrective or preventive actions in response to audit or inspection findings, tracks, and reports closure of items, and provides management visibility to areas of risk or concern.
• Oversees continuous improvement of Inspection Readiness processes and activities, including policies, procedures, and training related to inspections.
• Responsible for inspection record archival and maintenance in QMS.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives (eligibility may vary based on role).
• Paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree