GxP System Manager Consultant

Sage Therapeutics is looking for a GxP IT professional with a strong eye for detail to assume overall technical responsibility for GxP system management and maintenance of assigned GxP systems. This individual will be responsible for ensuring assigned systems maintain a “Inspection Readiness” state by managing system releases, user access and controlled document versioning. As well as being responsible for ensuring Business needs of the system are met by working with key stakeholders to understand business requirements to help the business achieve those requirements through process or system improvements.

Roles and Responsibilities (Essential Functions)

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 and assess their potential impact on Sage system configuration and processes. 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. 

Experience, Education and Specialized Knowledge and Skills

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.

Basic Qualifications

• 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.

Preferred Qualifications

• 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.
• Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
• Excitement about the vision and mission of Sage.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described. Other duties may be added, or this description amended at any time at the sole discretion of Sage.

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Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

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We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.