Global Head of Inspection Management & Audit

Job Description

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 DescriptionGlobal Head of Inspection Management & AuditFoster City, CASummaryThe Global Head of Inspection Management & Audit is responsible for leading the following functions and is primarily responsible for overseeing all aspects of the control of quality. This includes product inspections, ensuring compliance with regulatory standards and with the Gilead Quality System while maintaining high product quality across the global supply chain. This will be achieved by implementing robust inspection protocols and control of act manufacturers, of contract laboratories, of Gilead’s global affiliates and distributors and of PDM internal sites and functions to guarantee adherence to quality standards.The Audit and Inspection teams to ensure a readiness program for GxP regulated areas in PDM, including those systems managed by external vendors. Ensures departmental inspection readiness by leading teams in developing inspection readiness scorecards, and ensuring the organization addresses industry inspection trends. Ensures the quality audit program is a systematic and independent examination that establishes whether the activities that Gilead performs are compliant with standard regulations and that they are effectively implemented to achieve the required objectives. This role supports the organization by providing processes to identify and manage compliance and inspection risks and escalate issues in a timely manner.Duties & ResponsibilitiesDeveloping and Implementing Inspection Strategies:

Design and implement comprehensive inspection plans for all manufacturing sites, including raw materials, in-process materials, and finished products, aligned with regulatory requirements.Establish standardized inspection procedures and methodologies across global operations.Oversee the implementation of advanced inspection technologies to enhance accuracy and efficiency.

Regulatory Compliance:

Stay abreast of all relevant regulatory requirements related to product quality, data integrity, and supplier management.Ensure compliance with regulatory agencies like FDA, EMA, and other relevant authorities.Prepare for and manage regulatory inspections.

Risk Management:

Identify and assess potential quality risks across the supply chain.Develop and implement risk mitigation strategies to minimize quality risks.

Quality Improvement Initiatives:

Lead continuous improvement efforts to enhance quality standards and operational efficiency.Analyze quality data to identify trends and opportunities for improvement.Foster a culture of quality throughout the organization.

Expectations as a member of the Quality Assurance Leadership Team:

Definition of the strategy for Quality Unit.Delivery of business goals in the Quality arena.Exemplary levels of personal and professional integrity.Collaboration with other functions within PDM QA.Collaboration with Kite and Gilead R&D Quality groups.Role modelling of the Gilead and PDM leadership behaviors, with full participation as part of the PDM eLT in the strategic and operational improvement initiatives for PDM.Ability to remain calm and take consequential decisions.

Supervisory ResponsibilitySupervises the leaders for the Inspection and Audit teams.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.Operational management of entire team including budget setting and monitoring, hiring and performance management of the team, definition of annual goals and individual development plans, and on-going coaching of direct reports.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.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 Conditions:Primarily working indoors in an office setting.Occasional Travel (5% of time) both domestic and international can be expected.

#J-18808-Ljbffr