Associate Director/Director IT-Quality

Profile

Specific Responsibilities:
* Bacheloras degree in Science or Technology, Masters or higher preferred; 15 years experience in IT and quality processes (for life sciences) including computerized system lifecycle processes and change management.
* Extensive experience in leveraging frameworks like GAMP5, PIC/S to comply with world-wide health authority regulations (21 CFR 11, Annex 11) and quality standards (ICH Q8, Q9, Q10).
* Exceptional interpersonal skills, including teamwork, facilitation, and negotiation.
* Strong leadership and project management skills. Excellent analytical, problem-solving and technical skills. Detailed oriented, systematic and rapid learner.
* Excellent planning and organizational skills. Exceptional written and verbal communication skills.
* Demonstrated leadership skills and provides guidance that is consistent with managing project teams within core IT and business processes.
Essential Duties and Job Functions:
* Lead transformative IT quality process improvements through the use of an IT Quality Manual that governs Gilead IT practices.
* Use change management tools (RACI, procedures, training, compliance metrics, etc.) to drive process structure and maturity.
* Optimize and manage methodology for developing user, functional and design requirements; installation, operational and performance qualification; standard operating procedures and requirements traceability.
* Optimize and manage a process for IT facilities/equipment commissioning and qualification.
* Develop a risk management process to manage the full life-cycle of the GxP computerized systems.
* Manage and develop staff that are responsible for computer validation and IT quality systems operations.
The AD/D assimilates the global validation and IT security strategy and provides guidance to support local and remote sites. The AD/D is also responsible for working closely with the IT leadership to ensure that in-house and third-party engineering and operational processes are streamlined, efficient, and GxP-compliant. The AD/D also provides guidance and instruction for the control and compliance of all computerized system used in GxP operations.
Knowledge, Experience and Skills:
Bacheloras degree in Science or Technology, Masters or higher preferred; 10 years experience in pharmaceutical processes including systems lifecycle processes, change control and computer validation.* Exceptional interpersonal skills, including teamwork, coordination, facilitation, and negotiation. * Strong leadership and project management skills. * Excellent analytical, problem-solving and technical skills. * Detailed oriented, systematic and rapid learner.* Excellent planning and organizational skills. * Exceptional written and verbal communication skills.* Demonstrated leadership skills and provides guidance that is consistent with managing project teams within core IT and business processes.
Functional Area:
IT
Position Type:
Regular
Shift:
Days
GILEAD
Web: ****

Company info

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