Quality Systems Consultant

Description

Sage Therapeutics is searching for a creative, resourceful, integrative thinker for a role as a Quality Systems Consultant.  The successful candidate will work as part of the Quality Systems Business Administration team to provide business analysis, administration and configuration support for GxP Computerized Systems in the Quality Systems department.

Roles and Responsibilities (Essential Functions)

• Analyses, develops, tests, and deploys configuration, workflow, and/or reporting to improve the overall accuracy, efficiency, and effectiveness of the GxP computerized system

• Perform business analysis working with stakeholders to gain an in-depth understanding of business requirements.  Assist in gathering user requirements for GxP Computerized Systems

• Support the migration of GxP documents/records and Business Process Owner activities for Qualified SharePoint

• Performs Business Administration tasks supporting GxP Computerized Systems in Quality

• Author work instructions for Quality System processes supporting GxP Computerized Systems

• Conduct end user training for GxP Computerized Systems

• Support future rollouts and continuous improvement initiatives for GxP Computerized Systems

• Review and approve validation deliverables as part of continuous improvement and/or rollouts of additional modules and systems

• Effectively identifies and resolves system issues and appropriately communicates gating items to management and stakeholders

Experience, Education and Specialized Knowledge and Skills

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, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

Basic Qualifications

• BA/BS or equivalent combination of related education and experience

• 6+ years of Quality and/or IT experience in the biotech/pharmaceutical industry

Preferred Qualifications

• 2+ years of experience as a SharePoint super user

• Strong working knowledge of Quality Systems and GxP requirements and applicable regulations (e.g. FDA 21 CFR Parts 11, 210, 211, EU Annex 11 and 15, ICH guidelines, etc.) with the ability to assess compliance risks

• Demonstrates in-depth understanding of system administration and problem resolution

• Experience as a Business Analyst in support of GxP Computerized Systems

• Experience in utilizing Veeva Vault Quality (e.g. Quality Management System and Quality Docs)

• Experience in implementing and maintaining GXP computer systems in a validated state

• Experience authoring, revising, reviewing, and approving procedures and/or work instructions

• Experience reviewing and approving validation documentation (such as User Requirements Specifications, Configuration Specification, Traceability Matrix, Performance Qualification Test Scripts, User Acceptance Testing, etc.)

• Strong team player with a customer service approach and solution-oriented

• Excellent communication skills (interpersonal, verbal and written) and collaboration skills

• Attention to detail and ability to work individually and within a multi-disciplinary team

• Excitement about the vision and mission of Sage

• Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways

Job ID: R001926

#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.

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.

EEO is the Law

EEO is the Law - Supplement

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

Employment applications are processed through a website that is not owned or controlled by Sage Therapeutics, Inc. Sage Therapeutics, Inc. makes no representation as to the accuracy of the information contained on websites it does not own or control. Sage Therapeutics, Inc. does not recommend and does not endorse the content of any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

#LI-Remote