Global Quality Systems ManagerWilmington, DE USA
- The primary objective of this position is to assure compliance of computerized GMP systems to Life Science manufacturing and systems regulations (21 CFR Part 11, GxP, GAMP, etc.)
Essential Duties and Responsibilities
- Provides guidance and oversight of the procurement, installation, validation, integration, modification, operation and maintenance of any existing or incoming computerized systems designated as GMP.
- Perform business requirements gathering, requirements analysis, user testing, and system validations (IQ, OQ, PQ and RQ) as needed.
- Responsible for identifying and partnering with responsible system owners to ensure availability, security, compliance, maintenance, and support of GMP computerized system, including the security of the data residing on that system.
- Functions as Centralized Process Owner for computer compliance of SPI systems that are designated as GMP.
- Maintain external landscape awareness to communicate changes in computerized system regulation or guidelines that might impact SPI systems or systems governance.
- Develops global policies and procedures for managing life cycle of computerized system.
- Supports sites with lifecycle management and activity planning.
- Troubleshoot problems with existing configurations, master data, mega data selection lists, interfaces and reports.
- Support Quality Systems User Communities in building operational efficiencies and enhanced data integrity compliance.
- Assist in the identification and planning of new system solutions and enhancements to meet evolving business needs.
- Functions as Administrator/Super User QMS systems. Provide training and knowledge share/transfer to other Super Users.
- Provide computer systems management support to other SPI functions as needed.
- Follow applicable standards and applicable GxPs
- Manage quality & regulatory projects, as needed.
- Perform other duties, as assigned.
Education, Skills and Experience
- Bachelor’s degree in Computer Science or equivalent
- 5 years of experience with: requirements gathering, workflow design, configuration and documentation with Master Control (or equivalent)
- Proven skills in relationship building, customer-focus, decision-making and problem solving
- Superb customer facing, communication, time management and organizational skills
- Experience with QA environments and systems
- Experience in Life Science manufacturing and systems regulations (21 CFR Part 11, GxP, GAMP, etc.)
- Must have excellent communication skills and the ability to work with various levels of staff.
- Must be able to work in a deadline-oriented, face-paced environment.
- Occasional travel to other SPI sites and other occasional business-related travel as needed