General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role as a Senior Manager, Quality Assurance Information Technology (QA IT). In this position, you will interface and build strong partnerships with other teams within SAGE to ensure appropriate Quality oversight of Computerized Systems Validation (CSV) activities and data integrity controls throughout the lifecycle of our GxP systems.
Roles and Responsibilities
Provide QA oversight and support of business and CSV activities throughout the lifecycle of GxP systems.
Review and approve CSV deliverables, GxP change management requests, and quality records (e.g., Deviations, and CAPAs) to ensure adherence to Quality requirements.
Review plans and provide day-to-day QA guidance and support to initial validation and controlled change-related initiatives, identify issues, and communicate Quality requirements.
Serve as a subject matter expert (SME) in CSV requirements and data integrity controls.
Develop and/or refine QA IT related procedures, work instructions and templates.
Enhance data integrity controls.
Support audits for vendor qualification or requalification.
Collaborate across functions and within Quality to identify areas of improvement and implement enhancements.
Provide guidance to cross functional team, educate and train as necessary on risk-based approach for deployment of GxP systems.
Support Inspection Readiness initiatives, as well as during audits and regulatory inspections.
May supervise consultants.
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 important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations. Must have a 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.
5+ years of experience in the biotech or pharmaceutical industry with QA responsibilities.
7+ years' experience in Quality Assurance IT
Thorough working knowledge of computer system validation and data integrity controls.
Expertise in 21 CFR Part 11 and EU Annex 11 regulations, data integrity and GAMP5 concepts, applications, and best practices.
Hands-on experience in implementing and maintaining data integrity controls including audit trail review.
Experience supporting regulatory inspections and audits.
Demonstrated ability to apply risk-based approaches to information system selection, testing, implementation, and maintenance.
Experience consulting with key business stakeholders. An ability to influence for greater outcomes.
Strong team player that has a customer service approach and is solution oriented.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Possesses strong written and verbal communication skills.
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.
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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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.#LI-Remote
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