Senior Manager, RA Quality and Compliance Excellence

For Current Gilead Employees and Contractors:

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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
 

Regulatory Affairs (RA) Business Operations believe talented people deserve a great place to work and excellence in our day-to-day operations enables talented people to do their best work!  Our Mission and Purpose is to reduce complexity, improve performance and to differentiate value.  In doing this we unleash and enable our people to be purposeful and impactful!
 

The RA Quality & Compliance Excellence function, part of RA Business Operations, collaborates across Global Regulatory Affairs (GRA) to ensure that regulatory processes and practices adhere to the highest standards of quality, compliance, and operational efficiency. This is accomplished by working closely with other RA Business Operations functions, such as Business Process Excellence (BPE) and Communications & Engagement, as well as external teams throughout the Development organization. This role will lead transformational change within the GRA while also implementing robust and engaging learning experiences and effective communication strategies for all employees. They will serve as the functional expert with respect to L&D and change management. This role may require oversight of external vendors as well as coaching and training to vendors and internal colleagues. The ideal candidate will possess extensive experience in regulatory affairs, with a strong emphasis on fostering continuous improvement, compliance, and effective cross-functional communication in a dynamic biotech environment.

EXAMPLE RESPONSIBILITIES:

Learning & Development (L&D):

• Lead L&D Strategy: Develop and execute a comprehensive L&D strategy aligned with business objectives, regulatory requirements, and industry standards, while driving organizational growth, enhancing employee performance, fulfilling individual development needs, and fostering a culture of continuous learning and improvement.
• Content Development & Management:
  • Oversee the creation, curation, and delivery of high-quality training materials covering regulatory compliance, product knowledge, leadership development, and soft skills across various formats (eLearning, workshops, simulations, etc.).
  • Manage the Regulatory Affairs L&D content repository and learning portal, ensuring easy access to current, high-quality training materials and resources.
  • Organize and categorize content to facilitate efficient navigation and retrieval, applying best practices for knowledge management.
  • Regularly audit and update the repository to stay aligned with evolving regulatory requirements, industry trends, and internal needs.
  • Collaborate with functional and cross-functional teams to ensure content relevance, engagement, and accessibility.
  • Participate actively in the RSQ Podc