San Francisco, California · Biotech/Pharmaceutical
Title: ERP GxP IT Systems Analyst with Pharma Type of role: 12+ Months - Contract Client Location: San Francisco, CA (Remote0
* Must have previous experience in a Pharmaceutical or Biotech domain.*
We are seeking an IT GxP System Owner to assist with the implementation, management and support of internal GxP ERP systems to ensure the Supply Chain group is fully enabled. You will facilitate discussions with business leads and users to evaluate IT GxP systems and implement improvements that are consistent with business processes. Additionally, you will work with multiple teams, vendors, and Managed Service Providers to oversee GxP requirements of the ERP system and focus on change management, GxP compliance and support.
Qualifications / Responsibilities:
Support selection, implementation, validation and operational maintenance of GxP Systems to support Tech Ops CMC, Manufacturing and Supply Chain teams.
Collaborate with Tech Ops CMC business team and align the appropriate technology solutions to provide improved functionality, process efficiency and accuracy
Perform hands-on configuration and troubleshooting to ensure efficient ERP system operation.
Guide vendor and system evaluations and selections by applying business experience to identify solutions complementary to the company strategic programs.
Oversee the work of external Managed Service Providers for responsible systems to ensure that system issues are resolved promptly
Manage system implementation and support for system upgrades and routine maintenance while overseeing GxP compliance.
Oversee all aspects of delivery inclusive of planning, requirements, design, configuration, testing, deployment and production support for ERP solutions that meet Tech Ops needs.
Perform project management for small to medium projects and operations IT Change requests.
Help create technology roadmaps and support IT Strategy to create Enterprise Architecture for client IT systems.
Establish best practices to ensure that our customers with a focus on Tech Ops CMC business groups are supported, and our systems are maintained in a validated state.
Bachelor's degree in a relevant field, including Business, Sciences, IT or Engineering and 8 plus years of experience or equivalent
5+ years technical experience, including system administration supporting ERP systems.
5+ years supporting internal business systems or implementing systems
3+ years of excellent project management experience for GxP systems implementation
Working knowledge of CFR Part 11/Annex 11, Computer Systems Validation and IT Processes such as Backup/Restore and Disaster Recover