10+ Years experience setting up, implementing, maintaining, enhancing, IT systems in GXP environments.
Proven expertise in integrating systems and data flows across varied platforms, environments, and systems.
Ability to drive the plan, design, and build of IT architectural solutions at the network and application level for GXP systems.
In-depth knowledge of CFR Part 11/GxP software qualification and data management for GXP systems.
Data integrity and management for GxP systems.
Data resiliency - backup, restore, archive.
Experience with annual account reviews and system periodic reviews.
Experience with GMP data quality assessments and managing deviations.
Experience in planning, documenting, and implementing IT resiliency/Disaster Recovery solutions.
Ability to lead; converse with the team, use collaborative skills to vet recommendations and obtain agreement.
Ensure technical solutions are aligned with business goals and objectives.
Provide technical guidance and support to business and IT teams
Collaborate with cross-functional teams to ensure that technical solutions are integrated with other systems.
Experience gathering business requirements, software testing (UAT, IQ, OQ), creating and writing SOP's and GXP validation documentation (including IT System Administration Guides).
Responsibilities:
Manages document creation, review, and approval for GxP and non-GxP environment and systems.
Manages requirements gathering, prioritization and negotiation with business stakeholders to ensure the total solution delivered meets or exceeds expectations.
Maintains and influences business process and technical architecture design; validates and interprets business needs by conducting feasibility studies and drafting business cases.
Uses knowledge of business operations and Business Process Mapping to articulate business and data flows for the purpose of operational and technical improvement.
Ensures delivered solutions are compliant with associated federal regulations (GMP, GxP).
Establishes and nurtures relationships with relevant colleagues from the IT and business teams.
Learn and become proficient in relevant IT processes; e.g., Change Management, Technical Operations, Lab Technical Support.