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

FUNCTION: Regulatory Affairs Business Operations – Quality & Compliance Excellence (QCE)

POSITION OVERVIEW:

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 Podcast Club and cross-functional L&D forums to promote knowledge sharing and collaboration.
  • Use data analytics to track content usage, identify improvement opportunities, and enhance the overall learning experience.
• BPE Academy Leadership:
  • Lead and manage the BPE Academy, providing strategic direction and overseeing core offerings such as Six Sigma, change management, and project management training.
  • Develop and curate practical resources, tools, frameworks, and templates to support successful initiatives, process improvement workshops, and change management efforts.
  • Design and deliver “Train the Trainer” programs to empower internal trainers to effectively deliver BPE Academy content, nurturing a culture of continuous improvement.
    • Provide ongoing support and mentorship to trainers, including regular refreshers, feedback on delivery techniques, and maintaining high instructional standards.
    • Cultivate a network of internal trainers to share best practices and collaborate on ensuring consistency and quality across teams and functions.

Change Management:

• Lead Change Initiatives:
  • Develop and execute change management plans for major projects, using methodologies like ADKAR and Prosci to guide implementation, communication, and evaluation.
  • Conduct impact assessments, manage resistance, and lead stakeholder engagement, ensuring clear and consistent communication throughout the change process.
  • Create change communication plans to promote awareness and acceptance, and establish success metrics to evaluate and adjust strategies for continuous improvement.
• Drive Continuous Improvement:
  • Work with R&D and Quality teams to analyze deviations and CAPAs, ensuring changes are documented and sustainable.
  • Partner with Business Process Excellence leaders to implement process improvements, aligning change management with broader optimization goals.
  • Track improvement success, gather feedback, and adjust strategies for long-term adoption and efficiency. Promote ongoing change management training and development.
• Data-Driven Decision Making:
  • Monitor KPIs related to change adoption, employee engagement, and performance to assess change initiatives.
  • Use data to inform learning strategies and identify areas for improvement, adjusting tactics based on insights.
  • Provide regular reports on change progress and foster a culture of data-driven decision-making in projects and initiatives.
• Additional Responsibilities:
  • Serve as a subject matter expert on change management, guiding the organization on tools, resources, and best practices.
  • Maintain a repository of lessons learned and best practices to support continuous improvement.
  • Ensure integration of change management into project management frameworks and support leadership in building organizational change capability.
  • Support Business Operations leaders in drafting, refining, and distributing email communications, ensuring messages are clear, engaging, and aligned with strategic priorities and tactical guidelines.

Communication:

• GRA SharePoint Communication Platform
  • Oversee the global regulatory affairs SharePoint platform, ensuring it is up-to-date, user-friendly, and serves as a central hub for resources and communications.
  • Manage content governance, including the creation, organization, and approval processes for materials to accessibility across GRA.
  • Collaborate across GRA to ensure seamless integration updates and communications, providing training and support for effective platform utilization.

• Video Log
  • Edit and produce Leader Video Logs to enhance clarity, engagement, and ensure brand consistency.
  • Support leaders in the scripting, delivery and recording of video messages, ensuring they align with communication goals and are of high quality.
• GRA Email Communications
  • Manage and distribute internal communications via First Up, ensuring timely and targeted messaging.
  • Support leaders in drafting and refining email communications, ensuring messages are clear, engaging, and aligned with strategic priorities.
  • Ensure all communications adhere to internal brand guidelines and maintain a consistent tone of voice.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• Extensive years of experience in the biotechnology or pharmaceuticals industry
• Experience managing and collaborating with virtual or remote teams; this role is an onsite role
• Experience with SharePoint administrator activities

Knowledge & Other Requirements

• Fluency in project management platforms/software
• Familiarity with highly regulated industry environments or drug development
• Excellent program and project management, consensus-building, and leadership skills
• Knowledge of Six Sigma or other process improvement methodologies
• Exceptional verbal and written communication skills and interpersonal skills
• Ability to collaborate across the organizational hierarchy and cross-functionally
• Experience managing teams in a business operations or technical processes environment
• Has developed organizational skills; is detail oriented; and able to work in a fast-paced, deadline-driven environment.
• Ability to work independently on basic job duties and understands criticality and time expectations of assigned activities and prioritizes as appropriate
• Displays flexible thinking and willingness to adapt to changing approaches based on project needs and expectations.
• Capable of using advanced functions of various software applications, particularly the Microsoft Office Suite, Adobe Acrobat, and SharePoint
• Strong experience in internal communications, digital content management, or change communications within a corporate environment.
• Proficiency with video editing tools for vlog production.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively “Gilead” or the “Company”) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).

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