Website Gilead Sciences
Gilead Enterprise Data and AI Platform team is looking for a GxP Platform Operation Manager to lead the qualification, commissioning, operation, and sustainment activities of an GxP qualified Enterprise Data & AI Platform and its associated services.
The GxP Platform Operations Manager leads the GxP qualification activities for our Enterprise Data & AI Platform as well as supervises vendor partners to handle support cases and incidents, following well documented runbooks to achieve target service levels. The Platform Operations Manager has a secondary role to work with other Platform development teams within to design, develop and migrate appropriate activities into the operation portfolio to achieve expense and/or service level (e.g. 24×7 response) targets.
- Lead and supervise day to day operation and sustainment tasks and functions, including incident and change management.
- Ability to extract and review data that reflects team performance against KPIs.
- Drive continuous improvement of existing GxP systems and processes.
- Ensure successful and smooth transition from the project phase to the operational phase.
- All other projects and duties as required or assigned
- Facilitate issues and escalations between Platform adopters and related teams to drive resolution and achieve SLAs, customer satisfaction
- Contributes to the achievement of established department goals and objectives and adheres to department policies, procedures, quality standards, and safety standards
- Assure maintenance and adequate lifecycle management of the GxP systems under their responsibility.
- Serve as a direct escalation resource for the Platform adopters needing additional resources or urgent attention.
- Accountable to SLAs and quality standards, including regular support reviews to identify trends and areas for improvement.
- Ensure successful qualification of all GxP systems in the Enterprise Data & AI Platform ecosystem.
- Be the system owner for some GxP systems.
- Mentor team members by giving/receiving actionable feedback.
- Knowledge of data management systems and big data solutions
- Established project management skills
- Proven experience in managing relationships with vendors/consultants, IT teams and internal stakeholders
- Experience in a supervisory role on an integration development team
- Bachelor’s degree in Computer Engineering/Science, a related technical field involving coding (e.g., physics or mathematics), or equivalent practical experience.
- Knowledge of GxP (Good Clinical/Manufacturing/Documentation practices)
- 8+ years of industry experience, 5+ technical leadership and system integration experience
- Excellent communication skills in English, both written and verbal.
- Experience in operational management and sustainment of enterprise platforms and applications.
- Experience in writing GxP process documentation, SOPs, and training.
- Hand-on experience in Building and Qualification of the new systems in the GxP environment.
- Knowledge of cloud infrastructure, connectivity, data integrity and cyber security.
- Familiarity with public cloud computing services (AWS preferred)
Company: Gilead Sciences
Vacancy Type: Full Time
Job Location: Raleigh, NC, US
Application Deadline: N/A