VP, Site Head, La Verne

United States - California - La VerneProcess/Product Development & OperationsRegular

Descrizione del lavoro

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.

We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

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. Join Gilead and help create possible, together.

Job Description

Business Overview

At Gilead, we’re committed to creating a healthier world for everyone – no matter the challenges ahead of us. For more than 30 years, we’ve pursued the impossible, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases. Through bold and transformative science, we’re driving innovation that has the potential to become the next generation of life-changing medicines. Our ambition is evident in our mission. Because the impossible is not impossible. Creating Possible drives everything we do. It’s evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving lives of people around the world. For us, nothing is impossible – because of the people we work with, the communities we stand with and the partners we push forward with. Our ~12,000 employees band together through science, grit, compassion and courage to prove the impossible wrong. At Gilead, the tangible results of your contributions are evident. Where every individual matters. Where all employees can enhance their skills through ongoing development. And where we start every day with one question: “What’s next?”

Job Purpose

The Vice President and Site Head provides strategic leadership and oversees daily operations at the La Verne site. This leader will bring rigorous operational discipline and manufacturing expertise in a GMP environment, while also inspiring and implementing a cultural evolution at this strategically critical site within the Gilead global network, with a mandate to embrace best-in-class methodologies and build influence and followership through a cross-functional mindset.

The Site Head will embrace the valuable heritage and historical success of the site, while also leading the team forward toward higher measures of performance. As the Gilead global manufacturing network integrates around shared strategic priorities, this leader will have a critical voice in helping to shape a ‘’One Manufacturing’’ mindset across the global enterprise of Gilead sites and third-party partners.

The role is accountable for clinical and commercial sterile drug product across both small and large molecule modalities. Responsibilities include clinical and commercial cGMP manufacturing, production logistics, safety, quality, and compliance at the site. The role will be based in La Verne, California.

Key Accountabilities

Develop medium and long-term strategic objectives for the clinical and commercial manufacturing at the site and lead the management team in the development and implementation of annual operational plans. Communicate and create buy in for the business plans and vision for the future to ensure strategic goals are achieved.
Lead by example in engaging functional leaders at and outside of the site to champion and implement technology innovations, including implementation of best-in-class continuous improvement tools such as Lean/Six Sigma. Maintain the right to operate and highest safety standards at the site, including performing ongoing analysis and management of risk across the site to ensure business continuity. Lead with integrity and transparency and in full compliance with laws and regulations.
Engage and lead the site leadership team and build a highly capable, diverse organization of more than 500 FTE employees through the attraction, development and retention of the necessary skilled professionals to meet short- and long-term business needs. Anticipate shifts in industry trends and the global regulatory environment that could impact Gilead’s business needs and position the site’s resources and capabilities to respond accordingl
Partner on capital projects with Technical Development, Quality Assurance and Corporate Engineering to ensure on time and on budget delivery of new manufacturing capabilities to meet future demand for the Gilead portfolio of products.
Build a partnership mindset across the La Verne site – and more broadly across Gilead – by engaging and influencing cross-functional leaders and other stakeholders for the site to become a sought-out partner to drive new ideas and projects forward at the site.
Lead the development of the site manufacturing budget in collaboration with departmental heads and guidance from the head of global manufacturing. Manage expenses in accordance with the approved budget. Maintain a detailed budgetary analysis and proactively act upon budget deviations.
Ensure support from the site to partner with Technical Development to ensure rapid bench to plant execution of safe, flexible, and compliant clinical manufacturing, as well as the coordination of internal site tech transfers from pilot scale to commercial scale production for sterile drug products.
Take an active role in shaping a ‘’One Manufacturing’’ mindset, along with the definition of common operating principles/metrics, across the Gilead manufacturing enterprise.

Key Requirements

Experienced understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP) and/or ISO, as well as solid knowledge of worldwide regulatory requirements.
Excellent verbal, written, and interpersonal communication skills are required. Must possess excellent influencing skills.
Demonstrated success in developing a strategy that delivered results in a manufacturing environment.
Expertise and track record in effectively partnering with quality in a regulated manufacturing environment.
Expert project management skills, including definition and tracking of operational KPIs in a plant setting.
Track record of attracting, developing, and retaining a high-performance, diverse team.
Possesses in-depth knowledge of industry best practices.
Strong working knowledge of relevant regulatory guidance, including pharmaceutical GMPs and ICH guidance.
Knowledge of and successful implementation of best-in-class continuous improvement methodologies.
Prior success in working effectively with scientific, technical and operations staff in a plant setting.
Experience in building cross-functional relationships that demonstrate a willingness and ability to influence others to work toward shared objectives.
Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.

Qualifications

20+ years of relevant experience and an undergraduate degree in a scientific or technical field (i.e., biology, chemistry, engineering).
An advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA is desirable.
Experience leading a biologic or a small molecule manufacturing site (highly preferred).
Experience in sterile drug product manufacturing (highly preferred, but open to consider top manufacturing talent without sterile experience).
Experience in supporting regulatory filings including IND and BLA/NDA and post-marketing submissions.
Experience working with internal and external manufacturing organizations, including success in building partnerships with stakeholders outside of a manufacturing environment.
In-depth understanding of ICH guidelines and GMP requirements.
Solid understanding of current industry trends and regulatory expectations associated with pharmaceutical manufacturing areas, including new technologies, continuous improvement tools and approaches.
Exceptional interaction, leadership and communication skills are required.
Leadership qualities of the successful candidate include the following: developing high performing teams, cross functional engagement and influence, collaboration, and strategic vision.
Experience with Lean or Six Sigma is highly desired.

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