DEC, TechOps Consultant

General Scope and Summary

The DEC, TechOps Consultant will serve as an expert resource, collaborating with multiple functions such as TechOps, Quality IT, DEC Infrastructure, external partners, and DEC CSV (Computer System Validation).This role is responsible for supporting the Pharmaceutical Development, Manufacturing, Supply Chain, and Quality efforts.Sage is a virtual pharma company, and all manufacturing and supply chain is managed through Contract Manufacturing Organizations (CMOs) and Contract Service Providers (CSPs).

Roles and Responsibilities

• Analyze business processes, design solutions for current and future needs, and assist in implementing recommended 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.

• In partnership with DEC CSV and Quality IT, assure that compliance with GxP and other regulatory requirements are successfully established and met during system implementations and life of system.

• Monitor and respond to system problems, tracking issue occurrence and resolution.

• Manage systems in a System Manager and/or System Administrator role.

• Provide oversight of external partners.

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

• Bachelors degree (scientific or technical discipline).

• 6+ years of experience in life sciences, medical devices, or consulting with demonstrated experience and results in providing digital technology and innovation support to Manufacturing and Quality processes.

Preferred Qualifications

• Knowledge of Manufacturing, Supply Chain, Stability, and Serialization systems.

• Experience with GxP validation methodology.

• Experience performing Business Analysis (BA), Project Management (PM), and System Administrator (SA) duties.

• Experience in Quality systems, GMP requirements, 21 CFR 820, 21 CFR 11, Annex 11, and ISO frameworks.

• Experience in developing business requirements and configuration specifications.

• Experience with data exchange, migration, and integrations.

• Oracle Supply Chain experience is a plus.

• 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, and Forge New Pathways.

• Excitement about the vision and mission of Sage.

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.