Quality Compliance Consultant

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 vendors across GxPs (good clinical, laboratory, manufacturing, pharmacovigilance, and information technology; GCP, GMP, GLP, GVP, IT, respectively), interfacing with both internal and external stakeholders.

The successful candidate is highly collaborative with experience in vendor oversight and management, review and completion of associated documentation, stakeholder engagement, and continuous improvement. Pragmatic, tangible, operational thinking, and direct experience are required. This role will require cross-functional collaboration with functional groups across GxP areas at SAGE and external auditors.

Roles and Responsibilities (Essential Functions)

• Support and contribute to the management of the GCP, GMP, GLP, GPV, IT Vendor Management Program by scheduling audits, reviewing audit reports and responses, following-up on audit responses, tracking audit actions to closure, completing internal audit documentation, and managing/maintaining vendor files. Aid in risk assessments to support program analysis and compliance.

• Support consultant auditors to ensure that audits, audit reports and other work products are of acceptable quality and in compliance with SAGE requirements, including consultant auditor contracts and training. May conduct or join audits.

• Provide status updates to stakeholders for audit lifecycle progress.

• 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 Compliance management for immediate and long-term resolution across SAGE.

• Open, track, and support quality events, deviations, corrective and preventative actions (CAPAs), and continuous improvements associated with vendors in accordance with applicable regulations, guidelines and SAGE SOPs.

• Provide support to Quality Compliance management by trending aspects of the Vendor Management Program on a routine basis for presentation to senior management for review.

• Support inspection readiness activities and the build of continuous improvement to the SAGE Vendor Management Program to ensure regulatory and industry standards are met.

• Possess excellent organization skills with the ability to take direction, and parallel process multiple audits and projects in an efficient and accurate manner.

• Possess excellent communication skills and represents the Quality group in a positive manner.

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 Quality Compliance management and key stakeholders to develop relevant and realistic plans 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

• BS degree with 4+ years related experience in the Biotech or Pharmaceutical Quality Assurance.

Preferred Qualifications

• Knowledgeable of GxP regulations and guidance across GCP, GMP, GLP, GVP, and IT.

• 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 audits of contract research organizations, laboratories (nonclinical and clinical), contract manufacturers.

• Experience managing Quality activities at all phases of the product lifecycle.

• Experience building relationships in working with external vendors.

• Excellent ability to adapt and take direction.

• Outstanding organization and communication skills.

• Excellent teamwork and collaboration 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.