GxP System Manager - Consultant

4 days ago

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Sage Therapeutics

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CNS disorders • Neuroscience • Brain Health • Mental Health • brain disorders

201 - 500

Description

• Lead the implementation and configuration of assigned GxP systems to meet business requirements. • Collaborate with cross-functional teams to gather system requirements and translate them into technical specifications. • Manage system upgrades, patches, and enhancements to ensure optimal performance and functionality. • Develop and maintain system documentation, including user guides, standard operating procedures, and training materials as per Sage procedures. • Administer user access and security permissions in accordance with Sage policies and regulatory guidelines. • Monitor system performance and troubleshoot issues to minimize downtime and maintain data integrity. • Conduct regular audits to ensure compliance with regulatory requirements, such as FDA guidelines for electronic records and signatures (21 CFR Part 11). • Provide support to end-users to maximize system utilization and efficiency. • Stay informed about new system features and updates. • Collaborate with BPOs, technical, validation and quality teams and external vendors to resolve technical issues and optimize system integration. • Support Dry run, formal test execution and defect management as per Sage validation procedures. • Support Inspection Readiness activities.

Requirements

• Must understand IT management governed by GxP standards. • Must be flexible and be able to think outside the box while remaining compliant. • Must be Detail-Oriented. • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations. • Minimum 7-years of IT System management including system upgrade and release management. • Minimum 5-years of GxP System exposure including crafting GxP Technical Documentation. • Minimum 5-years in Life Science industry, preferably Pharma. • Experience with DocuSign Part 11. • Experience with ComplianceWire. • Strong attention to detail. • Experience working with all levels of management and consulting with key business stakeholders. • An ability to influence for greater outcomes. • Strong team player that has a customer service approach and is solution oriented. • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. • Possesses strong written and verbal communication skills.