Head of CMC Regulatory Affairs - Strategy and Operations

Gilead Sciences, Inc.•Foster City, CA

45d

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

Requirements

Requires a PhD or MS with 14+ years of relevant professional experience, or BS with 16+ years of relevant professional experience - a degree in chemistry or a related scientific discipline is strongly preferred.
Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives.
Experience with CMC requirements for drug development of a range of product modalities.
Comprehensive understanding of the biopharmaceutical industry, R&D, and product commercialization, including the regulatory framework.
Experience designing, selecting, and implementing digital tools such as RIM, structured content authoring, LIMS, or GenAI applications with an enterprise mindset.
Understanding of structured content, automation, and enterprise knowledge systems.
Strategic thinking and ability to influence and constructively challenge the status quo.
Strong business acumen.
Ability to blend strategic acumen, regulatory fluency, and operational rigor with a strong background in change leadership, data governance, and digital transformation.
Experience in managing organizational cross-functional initiatives and/or business operations programs.
Ability to design and optimize organizations.
Excellent organizational and communication (both written and verbal) skills with all levels of an organization.
Ability to work and influence within a matrixed environment and regularly collaborate with cross-functional teams across Technical, Research, and Development.
Ability to manage multiple priorities, to draw out diverse views, and to show tact and discretion in challenging situations.

Responsibilities

Develop a roadmap that fosters innovation to assist where and when CMC RA invest resources and budget.
Own continuous improvement of the operating model and capability roadmap for the CMC RA function.
Creating and implementing functional business strategies
Improving performance and operational excellence
Centralizing key activities to support each team's global product, pipeline, and people's ambitions
Design, build, and lead a high-performing organization to drive strategic initiatives, centralize activities, and foster cross-functional support of CMC RA's processes, systems, data, and tools.
Define and track Key Performance Indicators for CMC RA.
Collaborate with other functions to ensure that CMC RA systems are operating seamlessly connected with the broader enterprise.
Partner with Regulatory Affairs, Quality, Technical Development, and Manufacturing stakeholders to align process and digital/data modernization strategies.
Support centralized resource management for CMC RA resources defined in Gilead's resource forecasting system (i.e., Planisware).
Manage CMC RA Operational Excellence activities with a goal of identifying synergies and efficiency across all CMC RA functions to reduce overall spending (responsible for leading the CMCRA leadership thought LRP, budget, etc.).
Manage cross functional teams, internal teams, and complex project teams (NPPs, RA / CMCRA teams, complex programs, etc.)
Oversee digital modernization of core CMC RA platforms (e.g., RIM) and integration across systems.
Stand up for CMC RA (with enterprise thinking) and oversee a digital/AI fluency and enablement team aligned to strategic priorities.
Create guidelines, systems, and processes for CMC RA knowledge management, in alignment and partnership with any broader initiatives in this space across the enterprise.
Lead workforce capability design, training strategy, and upskilling initiatives.

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.

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