Role Overview
As a Director in the Regulatory and R&D Quality Systems organization, you will serve as a thought leader and partner for Regulatory Affairs and R&D Quality stakeholders, focusing primarily on regions outside the U.S. to bring visibility into requirements that directly support business processes and users in those regions.
Location
Cambridge or Stockley Park, onsite 3 days a week.
Main Responsibilities
* Provide expertise, guidance, and leadership in Regulatory Information Management (RIM), Submission Management, Inspection Readiness, and AI technologies while applying an enterprise mindset.
* Manage escalations during critical system issues/outages, liaison with IT and Business to ensure impact is clear and support timely communication to end users through resolution.
* Represent Development Systems during inspections and audits as applicable.
* Mentor and guide other Development Systems team members in the U.K. on cross‑functional projects.
* Collaborate with team and leaders across geographic regions to ensure support and functional needs are met.
* Drive and serve as a knowledge resource on system evaluation of new or improving technologies to efficiently meet changing business needs.
* Act as subject matter expert on cross‑functional requirement gathering and implementation teams.
* Provide strong leadership and engagement with senior leaders, internal and external partners and stakeholders.
* Provide strategic input to future planning and development of the Development Systems Department.
* Oversee or act as a core project team member on specific projects.
* Interact frequently with other functional areas (Regulatory Affairs, R&D Quality, Patient Safety, IT).
* Represent Development Systems as a technical subject matter expert and main contact for projects.
Qualifications
* BA or BS in a scientific discipline, information systems, or equivalent, with 12+ years managing Regulatory Affairs systems or related experience; OR MS with 10+ years.
* Proven track record of driving change and strengthening capabilities in complex, multi‑functional organizations by introducing new technologies and processes.
* Ability to work with minimal direction and determine technical or business objectives of assignments.
* Solid understanding of change management methodology and execution.
* In‑depth experience in Regulatory Information Management technologies and the industry’s transformation with AI and other innovative technologies.
* Good understanding of computer system validation methodology, development, and execution.
* Extensive experience in the pharmaceutical/biotechnology industry, including global and regional roles in Regulatory Affairs and/or R&D Quality.
* Highly driven self‑starter with ownership, initiative, and ability to navigate ambiguity; resourceful and able to prioritize and focus.
* Strong leadership skills with the ability to set a clear vision, goals, and objectives to inspire innovative thinking and influence across functions.
* Experience working with cross‑functional teams is required.
* Exceptional interpersonal skills, including teamwork, facilitation, and negotiation.
* Demonstrated experience organizing ad‑hoc teams to achieve accelerated results.
* Excellent planning and organizational skills.
* Persuasive writer with strong verbal communication skills.
* Demonstrated ability to apply technical knowledge to oversight, troubleshooting, and training.
About Gilead
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—developing therapies that improve lives and ensuring access to these therapies worldwide. 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. We believe every employee deserves a great leader, and we’re looking for passionate, ambitious people ready to make a direct impact.
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