Associate Director, Gxp Systems

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.

Benefits and Compensation

The base salary hiring range for this position is $150,811 - $207,365.*

• The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, education, skills, and performance.
• This position is eligible to participate in the Company’s annual bonus plan; the bonus varies based on performance and is subject to the standard terms and conditions of the incentive program.
• To support your well-being, we offer a comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire. More information can be found in our Benefits Guide.

• Base salary ranges are periodically reviewed and subject to change. #LI-Remote