Associate Director, Operational and Digital Enablement, Regulatory Affairs CMC
Compensation
Not disclosed
Location
United States - California - Foster City
Work setup
Not specified
Seniority
Not specified
Employment
Not specified
Experience
8+ years
Category
Legal
Posted
Skills
ai
analytics
automation
data-quality
powerbi
process-improvement
six-sigma
vault
veeva
visio
Must have
10+ Years with BS/BA OR
8+ Years with MS/MA or MBA
Nice to have
BA/BS in Life Sciences, Engineering or related field preferred with relevant industry experience 10+ years with BS/BA; 8+ years with MS/MA/MBA
Experience in regulatory operations, CMC Regulatory Affairs, pharmaceutical development, or a related regulated environment.
Demonstrated experience leading business process design, mapping, optimization, or operational improvement initiatives.
Experience translating business needs into requirements and partnering with technology teams to implement digital or system-enabled solutions.
Experience leading complex, cross-functional initiatives in a global and highly matrixed organization.
Strong understanding of pharmaceutical regulatory processes and the regulatory lifecycle; experience with CMC regulatory processes strongly preferred.
Familiarity with regulatory information management, document/content management, workflow, data, analytics, automation, or AI-enabled solutions.
Experience with relevant enterprise platforms and tools such as Veeva Vault, Planisware, Signavio, Visio, Power BI, or similar technologies is desirable.
Demonstrated ability to analyze complex problems, structure ambiguous issues, develop recommendations, and drive work through implementation.
Strong facilitation skills with demonstrated ability to gather subject matter expert input and translate it into clear, practical end-to-end processes and requirements.
Strong communication and influencing skills with the ability to work effectively across functions and organizational levels.
Lean, Lean Six Sigma, or other process improvement training or certification is desirable; demonstrated practical application of process improvement methodologies is more important than certification
Full description
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
At Gilead, our pursuit of a healthier world for all people has led to a cure for hepatitis C, revolutionary advances in HIV treatment and prevention, and progress across viral and inflammatory diseases and certain cancers.
We set bold ambitions in our fight against some of the world’s most devastating diseases. We are united by a shared commitment to solving complex public health challenges and improving the lives of patients for generations to come.
Gilead is seeking an Associate Director, Regulatory Operations & Digital Enablement to advance operational effectiveness and digital enablement across CMC Regulatory Affairs.
This role will lead and support initiatives focused on business process design and optimization, digital and automation enablement, operational scalability, and effective implementation of new ways of working. The Associate Director will partner across CMC Regulatory Affairs, other PDM functions, Regulatory Affairs, and IT to translate business needs into practical, sustainable process and digital solutions.
The role requires a strong understanding of regulatory operations combined with demonstrated capability in process improvement, digital technologies, data, and change implementation. The successful candidate will be comfortable moving between business problems, process design, technology-enabled solutions, and implementation to improve how CMC Regulatory Affairs operates globally.
Key Responsibilities Regulatory Operations & Process Improvement
Lead business process mapping, analysis, design, and optimization initiatives across CMC Regulatory Affairs, including development, registration, post-approval, and lifecycle management activities.
Associate Director, Operational and Digital Enablement, Regulatory Affairs CMC at Gilead Sciences (United States - California - Foster City) — aijobsearch
Identify operational pain points, process gaps, inefficiencies, and opportunities for simplification or digital enablement in partnership with process owners and subject matter experts.
Apply structured problem-solving and data-driven approaches to evaluate root causes, assess options, and develop practical and sustainable solutions.
Facilitate cross-functional workshops and working sessions to define current and future-state processes, clarify roles and decision points, and establish implementation plans.
Support the development and maintenance of process standards, procedures, governance mechanisms, and operational controls that enable consistent execution across CMC Regulatory Affairs.
Develop and monitor operational measures and KPIs to evaluate process performance, adoption, and opportunities for continued improvement
Support portfolio, resource, and operational planning activities as needed, including use of enterprise planning and resource forecasting tools.
Digital Enablement, Data & Systems
Partner with the CMC Digital Enablement Head, business process owners, IT, and other stakeholders to identify and advance digital opportunities that address meaningful regulatory business needs.
Translate regulatory operational needs and process requirements into clear business requirements and use cases for digital, automation, data, and technology solutions.
Lead or support the implementation of digital solutions from business problem definition and requirements development through testing, deployment, adoption, and continuous improvement.
Establish and monitor success metrics for digital and AI-enabled capabilities including adoption, operational efficiency, quality, user experience, and business value realization.
Evaluate opportunities to apply workflow automation, analytics, artificial intelligence, and emerging technologies to improve regulatory processes and decision-making.
Support integration of regulatory processes, data, content, and systems to enable more connected and efficient ways of working.
Partner with data and system owners to improve data quality, usability, and availability for regulatory operations, analytics, and decision-making.
Develop dashboards, metrics, and operational insights that increase visibility into performance and enable data-driven decisions.
Support user acceptance testing, implementation readiness, change management, and adoption of new or enhanced digital capabilities.
Cross-Functional Delivery & Change Leadership
Lead complex cross-functional initiatives involving CMC Regulatory Affairs, Regulatory Affairs, Technical Development, Quality, Manufacturing, Supply Chain, Strategy & Operations, IT, and other relevant stakeholders.
Establish clear project objectives, scope, deliverables, roles, dependencies, and implementation plans for assigned initiatives.
Build alignment among stakeholders with differing priorities and translate complex operational or technical topics into clear business decisions and actions.
Develop recommendations and decision materials for CMC Regulatory Affairs leadership based on analysis of operational challenges, opportunities, risks, and potential solutions.
Partner with Regulatory Policy, Intelligence, and Health Authority Strategy colleagues to ensure processes and solutions remain aligned with evolving global regulatory requirements and expectations.
Drive organizational change initiatives to successfully implement new processes, digital tools, and AI-enabled ways of working, including stakeholder engagement, communications, training, adoption strategies and measurement of expected outcomes.
Promote effective process management and digital ways of working across CMC Regulatory Affairs by sharing tools, methodologies, lessons learned, and scalable approaches.
Basic Qualifications
10+ Years with BS/BA
OR
8+ Years with MS/MA or MBA
Preferred Qualifications
BA/BS in Life Sciences, Engineering or related field preferred with relevant industry experience 10+ years with BS/BA; 8+ years with MS/MA/MBA
Experience in regulatory operations, CMC Regulatory Affairs, pharmaceutical development, or a related regulated environment.
Demonstrated experience leading business process design, mapping, optimization, or operational improvement initiatives.
Experience translating business needs into requirements and partnering with technology teams to implement digital or system-enabled solutions.
Experience leading complex, cross-functional initiatives in a global and highly matrixed organization.
Strong understanding of pharmaceutical regulatory processes and the regulatory lifecycle; experience with CMC regulatory processes strongly preferred.
Familiarity with regulatory information management, document/content management, workflow, data, analytics, automation, or AI-enabled solutions.
Experience with relevant enterprise platforms and tools such as Veeva Vault, Planisware, Signavio, Visio, Power BI, or similar technologies is desirable.
Demonstrated ability to analyze complex problems, structure ambiguous issues, develop recommendations, and drive work through implementation.
Strong facilitation skills with demonstrated ability to gather subject matter expert input and translate it into clear, practical end-to-end processes and requirements.
Strong communication and influencing skills with the ability to work effectively across functions and organizational levels.
Lean, Lean Six Sigma, or other process improvement training or certification is desirable; demonstrated practical application of process improvement methodologies is more important than certification alone.
People Leader Accountabilities
Create Inclusion: Understand the business value of diverse teams, model inclusion, and embed the value of diversity in how teams are supported and led.
Develop Talent: Understand employees’ skills, experiences, aspirations, and potential, and provide the feedback, coaching, and insight needed to support their continued development.
Empower Teams: Connect teams to broader organizational goals and purpose, provide the support needed to remove barriers, and strengthen connections across the organization.
The salary range for this position is: $182,070.00 - $235,620.00. 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:
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.
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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.