Head of CMC Regulatory Affairs – Strategy and Operations

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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 teams global product pipeline and peoples 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 RAs 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 Gileads 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 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.

Digital & Systems Fluency

• 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 & 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.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.