Career Opportunities in the Foresite Capital Network

Job Title:

Associate Director, GxP System Management, Digital Enterprise Capabilities

Reports to:

Senior Director, GxP Quality & Development

Direct Reports:

N/A

General Scope and Summary

Sage Therapeutics is searching for a collaborative and resourceful Associate Director, GxP DEC Systems Management professional who will lead critical function of management, maintenance and evolution of GxP systems. This person will be responsible for enabling continual GxP risk management and improving operational excellence. As Lead system Manager, this role will ensure inspection readiness and compliance for GxP systems portfolio. The role will maintain, improve, and provide services for GxP system operational activities such as IT Change management executions, Data integrity assessments, User account reviews, user access management etc that are critical for compliance and success of GxP capabilities. Additionally, the individual will prioritize, align and deliver on key initiatives for GxP systems in collaboration with QA, cross functional DEC team, business stakeholders and CSV.

Roles and Responsibilities

• Lead and drive the system operational activities across GxP systems
• Assist with inspection readiness activities
• Lead organizational change management to support new/updated requirements for GxP systems compliance
• Streamline and improve processes for GxP systems compliance in collaboration with QA/IT , CSV , and the business
• Perform risk, value analysis with cross functional stakeholders
• Perform Demand management / capacity management for GxP system related requests
• Lead the prioritization process for GxP system needs
• Oversee and lead implementations / improvements in accordance with Sage operating standards
• Collaborate with users to develop and manage system documentation including, but not limited to, system specifications/configurations, SOPs, and training plans
• Establish process and frameworks in partnership with DEC CSV and Quality IT assurance for internal / regulatory requirements. Ensure successful change management and adoption across DEC organization.
• Work with System Admins/System architects / Platform leads for technical implementations.
• Govern and provide standards / best practices for GxP system change management/project execution practices for GxP systems
• Manage a team of external and internal consultants.
• Manage systems in a System Manager and/or System Administrator role
• Provide oversight of external partners
• Provide project leadership in planning, design, implementation, and support of TechOps applications

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop trusting relationships with stakeholders, good conflict management and negotiation skills, and the ability to analyze and breakdown complex issues.

Basic Qualifications

• Bachelor’s degree
• 6+ years’ experience providing digital technology and operational excellence support for GxP systems

Preferred Qualifications

• Bachelor’s degree in a technical or scientific discipline and 8+ years’ experience preferred
• Experience in the life sciences, medical devices, or consulting industries preferred
• 4+ years’ experience implementing and managing GxP systems in biopharma
• Experience leading GxP systems operations in support of Regulatory compliance and experience with GxP validation methodology
• 4+ years of technical experience with standard industry platforms/systems such as Veeva, Oracle, ServiceNow etc
• Experience performing Business Analysis (BA), Project Management (PM), and System Administrator (SA) duties
• Experience managing mid-large scale cross functional projects from inception to launch
• Experience in Quality systems, GMP requirements, 21 CFR 820, 21 CFR 11, Annex 11, and ISO frameworks
• Excellent planning, organizational, negotiation, conflict management, presentation, and time management skills
• Ability to support and prioritize multiple projects, both working independently and within a team
• Experience in developing business requirements and configuration specifications
• Ability to build trusting relationships cross-functionally and with our partners and vendors
• Experience with data exchange, migration, and integrations
• Flexibility to adapt to the dynamic needs of a growing biotech company
• Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, Forge New Pathways, and Work Fun
• 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.

Employment Type:

Number of Openings:

Job ID:

#Biotechnology #Careers #ThisIsSage

All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

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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Pay Transparency Nondiscrimination

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.