Executive Director, Global Head of Inspection Management

Location: Foster City, CA or Washington, D.C. with regular travel to Foster City, CA

SUMMARY/JOB PURPOSE:

The Executive Director, Inspection Management is responsible for leading and managing the inspection readiness program for GxP regulated areas in PDM, including those systems managed by external vendors. Activities include ensuring departmental inspection readiness, developing inspection readiness scorecards, and ensuring the organization addresses industry inspection trends. The Executive Director supports the organization by providing processes to identify and manage compliance risks and escalate issues in a timely manner.

ESSENTIAL DUTIES AND 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, as well as indirectly leading a community of Inspection Management groups at sites.
• 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, Supply Chain, 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.

SUPERVISORY RESPONSIBILITIES:

• Supervises direct reports.
• Indirectly leads staff through cross functional committees or teams, including inspection management and audit teams at manufacturing sites
• Supervision of contingent workforce and consultants
• Develops talent, including development planning, for both direct reports and indirect reports, through mentoring

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• 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/The Ideal for Successful Entry into Job:

• 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

Knowledge/Skills:

• 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.
• Withholds judgement to engage teams in addressing conflict positively by acknowledging dissenting opinions on contentious issues and facilitating identification of options to achieve an equitable solution.