Description
As a Director in the Regulatory and R&D Quality Systems organization, you are a thought leader and partner for Regulatory Affairs and R&D Quality stakeholders focusing primarily on regions outside of the U.S. to bring visibility into requirements that will directly support business processes and users in those regions. It requires a good understanding of current technology trends with a keen eye on innovation to help drive change in how technology can continue to transform and support the business in meeting key corporate objectives.
Cambridge or Stockley Park, onsite 3 days a week.
Main Responsibilities:
1. Provide expertise, guidance, and leadership in Regulatory Information Management (RIM), Submission Management, Inspection Readiness and AI technologies while applying an enterprise mindset.
2. 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.
3. Operate as a representative for Development Systems during inspections and audits, as applicable.
4. Mentor and guide other Development Systems team members in the U.K. on cross-functional projects.
5. Work with the team and leaders across geographic regions to ensure support and functional needs are met.
6. Serve as primary driver and knowledge resource within the team on system evaluation of new or improving technologies to more efficiently meet changing business needs.
7. Serve as subject matter expert on cross-functional requirement gathering, and implementation teams.
8. Provide strong leadership and engagement with senior leaders, internal and external partners and stakeholders.
9. Provide strategic input to future planning and development of the Development Systems Department.
10. Oversees or otherwise leads specific projects and /or acts as a core project team member
11. Interact frequently with other functional areas (i.e., Regulatory Affairs, R&D Quality, Patient Safety, IT).
12. Represent Development Systems as a technical subject matter expert and contact for projects.
Requirements:
13. BA or BS degree in a scientific discipline, information systems or equivalent, with a 12+ years managing Regulatory Affairs systems or related experience, or a MS degree in a scientific discipline, information systems or equivalent, with 10+ years managing Regulatory Affairs systems or related experience.
14. Proven track record of driving change and strengthening capabilities in complex, multi-functional organizations by introducing new technologies and processes
15. Works with minimal direction and exercises latitude in determining technical or business objectives of assignments.
16. Solid understanding of change management methodology and execution.
17. In-depth experience in Regulatory Information Management technologies and how the industry is transforming with AI and other innovative technologies.
18. Good understanding of computer system validation methodology, development, and execution.
19. Extensive relevant experience in the pharmaceutical/biotechnology industry including both global and regional roles, particularly in Regulatory Affairs and/or R&D Quality'
20. Highly driven self-starter, taking personal ownership and initiative, with an ability to navigate through ambiguity; exhibit resourcefulness and provide prioritization and focus
21. Exhibit solid leadership skills with an ability to set a clear vision, goals and objectives to inspire and drive innovative thinking and influence across functions
22. Experience working with cross-functional teams is required.
23. Exceptional interpersonal skills, including teamwork, facilitation, and negotiation.
24. Demonstrated experience organizing ad hoc teams to achieve accelerated results.
25. Excellent planning and organizational skills. Persuasive writer with strong verbal communication skills.
26. Demonstrated ability to apply technical knowledge to oversight, troubleshooting, and training.
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). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.