Director, Global External Manufacturing, OSD

Gilead Sciences • Foster City, CA

20d

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 fulfil their aspirations. Join Gilead and help create possible, together. Job Description KEY RESPONSIBILITIES Director, Global External Manufacturing Oral-Solid Dosage (OSD) leads a team to ensure uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This position is part of the Manufacturing Operations group within the larger Pharmaceutical Development and Manufacturing organization (PDM). The preferred candidate will have experience at managing, training, and mentoring staff. This role requires intimate collaboration at the Team Leadership level with the Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy organizations within PDM to ensure successful technology transfer, commercialization, launch, routine supply, and proactive management of changes across the product lifecycle from launch to sunset/divestiture.

Requirements

• Demonstrated track record in oral solid dosage drug product manufacturing and supply chain execution in the pharmaceutical industry
• Expertise in supply risk management, possessing in-depth knowledge of industry and system best practices
• Experience and/or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP).
• Solid knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance
• Solid understanding of the contract manufacturing organization (CMO) landscape; knowledge of CMO capabilities and limitations for worldwide drug product manufacturing is a plus
• Ability to travel internationally, including overnight, up to 10% of the time is required
• Exceptional verbal and written communication skills, including ability to interact effectively with senior management
• Demonstrated ability to understand and resolve complex situations
• Proven leadership capability to contribute to the success of PDM and Gilead
• 12+ years of progressively responsible experience in a pharmaceutical/biotech organization and a BA or BS degree in science or engineering, an advanced degree in science, engineering, or business is desirable
• An MBA degree can be substituted for 2 years of relevant experience, a Ph.D. degree can be substituted for 4 years of relevant experience
• Gilead Core Values Integrity (Doing What’s Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility)

Responsibilities

• Performs as a leader within Global External Manufacturing to execute the network strategy.
• Responsible for tactical manufacturing strategy, execution of the business with external manufacturing organizations, and management of supplier performance
• Partner in development of department strategy aligned with corporate and PDM goals into functional/departmental objectives to realize the targeted outcomes
• Proactively and effectively leads collaboration with functions within and external to PDM to achieve corporate, cross functional, and departmental goals
• In collaboration with Technical Development Organization, defines the technical requirements and actively partners with Global Supply Chain in selection of CMOs, and influences overall performance of the network CMOs to achieve Gilead’s strategic and tactical business outcomes, including Key Performance Indicators
• Proactively partners with Technical Development and internal Gilead manufacturing sites for successful technology transfer and validation of new or existing processes/products to the identified CMO(s)
• Leads the regular, tactical management of CMOs to ensure Gilead’s products are manufactured in accordance with the registered process and approved Master Production Record
• Enables timely resolution of complex issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, Material Review Board associated investigations, finished product trending, and change control
• Fosters and facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability
• May represent Gilead as a liaison between the company and various governmental agencies as required

Benefits

• 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.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees