Description
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
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Analyze business processes, design solutions for current and future needs, and assist in implementing recommended improvements in accordance with Sage operating standards.
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Collaborate with users to develop and manage system documentation including, but not limited to, system specifications/configurations, SOPs, and training plans.
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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.
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Monitor and respond to system problems, tracking issue occurrence and resolution.
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Manage systems in a System Manager and/or System Administrator role.
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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
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Bachelor’s degree (scientific or technical discipline).
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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
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Knowledge of Manufacturing, Supply Chain, Stability, and Serialization systems.
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Experience with GxP validation methodology.
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Experience performing Business Analysis (BA), Project Management (PM), and System Administrator (SA) duties.
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Experience in Quality systems, GMP requirements, 21 CFR 820, 21 CFR 11, Annex 11, and ISO frameworks.
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Experience in developing business requirements and configuration specifications.
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Experience with data exchange, migration, and integrations.
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Oracle Supply Chain experience is a plus.
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Flexibility to adapt to the dynamic needs of a growing biotech company.
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Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
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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.
Job ID: R001901
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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.
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.
EEO IS THE LAW
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.
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.
Employment applications
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