Head of CMC Regulatory Affairs – Strategy and Operations

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

Strategy & Capability Building

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

Operations & Cross-Functional Leadership

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.)

Digital Enablement

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.

QUALIFICATIONS

Domain Knowledge & Experience

Requires a PhD or MS with 14+ years 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.

Digital & Systems Fluency

Experience designing, selecting, and implementing digital tools such as RIM, structured content authoring, LIMS, or GenAI applications an enterprise mindset.

Understanding of structured content, automation, and enterprise knowledge systems.

Strategic & Operational Leadership

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.

Influence, Communication, & Executional Excellence

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.

The salary range for this position is : $302,005.00 - $390,830.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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.

For jobs in the United States

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or other non-job 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 ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE : EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT.

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.

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