Executive Director Global Head of Inspection Management
Executive Director Global Head of Inspection Management
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 255425 - 330550
1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were 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
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 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 Gileads 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.
- Models team spirit culture and ethics builds highperforming teams to meet company objectives.
- Sets objectives for teams and direct reports builds team members 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 crossfunctional 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 crossfunctional projects.
WORKING CONDITIONS:
- Primarily working indoors in an office setting.
- Occasional Travel 5 of time) both domestic and international can be expected.
For additional benefits information visit:
For jobs in the United States:
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 disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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.
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
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 apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Exec
Employment Type
Full-Time
