Executive Director, Global Head of Inspection Management

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (~~~) to apply for this job.

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 fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

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 GDPs 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.

• Manages internal logistics during Inspections, Mock inspections, or Audits 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 staying 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 (Quality Management System).

People Leadership Responsibilities:

• Model and Create an environment of inclusion.

• Empower Teams to achieve their department and corporate goals, removing barriers to success and growth.

• 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 Required:

Education/Experience:

• BS/BA degree in Biology, Sciences, or related discipline and a minimum of sixteen (16) years of related experience; OR MS/MA degree in Biology, Sciences, or related discipline and a minimum of fourteen (14) years of related experience; OR, PhD in related discipline and a minimum of fourteen (14) years of related experience.

Experience /The Ideal for Successful Entry into Job:

• Experience in the biotech or pharmaceutical industry is required.

• Prior demonstrated experience in managing Health Authorities during inspection is required.

• Demonstrated experience in managing Customer/Business Partners during inspection.

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.

• Models team spirit, culture, and ethics, builds high-performing teams to meet company objectives.

• Sets objectives for teams and direct reports, builds team member's capabilities, and promotes career development.

• Effective leader, comfortable in leading through ambiguity, proactively influences change.

Job Complexity :

• Capable of proactively assessing workload, trends, tasks, and priorities for cross-functional activity.

• Plans and executes multiple projects or activities, considering alternative methods and contingency plans to avoid potential issues.

• Designs and implements solutions to address cross functional project level challenges, taking into consideration the broader impact.

• Engages, influences, and collaborates with stakeholders on cross-functional projects.

Working Environment:

• Primarily working indoors in an office setting.

• Occasional Travel (expected 15- 20% the first year year in role) both domestic and international can be expected.

The salary range for this position is: $274,635.00 - $355,410.00. 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*.

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

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ~~~ for assistance.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (~~~) to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.