Sage Therapeutics Manager, Quality Systems in Cambridge, Massachusetts
General Scope and Summary
SAGE Therapeutics is searching for a resourceful, integrative thinker for an important and highly visible role that is responsible for Vendor Management oversight. In this position, you will be an integral contributor to the external auditing program for GxP vendors, interfacing with both internal and external stakeholders.
Roles and Responsibilities
Manage the GxP (GLP, GCP, GMP, GPV) Vendor Management Program by scheduling audits, reviewing and following-up on audit responses and tracking audit actions to closure.
Aid in the development of risk assessments to support program analysis and compliance.
Track CAPAs associated with key vendors in accordance with applicable regulations, guidelines and SAGE SOPs.
Conduct audits and manage individual consultant auditors to ensure that audits, resultant reports and other work produced are of acceptable quality and in compliance with SAGE requirements, including consultant auditor training.
Ensure audit deliverables (report, responses. corrective actions) adhere to internal timelines mandated in SAGE procedures related to CROs, CMOs and suppliers.
Monitor performance/compliance issues identified from a holistic view of vendors while demonstrating a “big picture” understanding of each vendor file.
Elevate systemic problems with appropriate recommendations/solutions to Quality management for immediate and long-term resolution across SAGE.
Provide support to SAGE Quality Management Review by trending aspects of the Quality Vendor Management Program on a routine basis for presentation to senior management for review.
Support the build of continuous improvement to the Quality System to ensure regulatory and industry standards are met.
Provides support to the Product Complaint Program.
May support internal audits.
Support additional Quality Systems functions as needed by reviewing Deviations, CAPAs, and Change Controls.
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.
- BS Degree with 6+ years related experience in the Biotech or Pharmaceutical industry.
Knowledgeable of GxP regulations particularly GCP, GLP, GVP and GMP.
Experience managing quality systems activities at all phases of the Product Lifecycle.
Experience building relationships in working with external Vendors.
Auditing Knowledge: Demonstrates knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company and to patient safety and data integrity. Preference to candidates with direct experience in conducting and/or leading the following types of audits: Internal, Clinical Investigator Sites, External CROs, Laboratories (clinical and non-clinical), and/or CMOs.
Outstanding communication skills
Excellent teamwork and collaboration skills.
Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
Excitement about the vision and mission of Sage.
Number of Openings:
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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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