General Scope and Summary:
SAGE Therapeutics is seeking a highly motivated, collaborative, resourceful, and results oriented Manager to support commercial and development GxP activities within the SAGE Quality Systems organization. The successful candidate will be responsible for managing vendor oversight systems and programs in support of SAGE pharmaceutical development, process development, analytical development and GCP clinical oversight.
Roles and Responsibilities:
- Provide SAGE oversight of GxP Vendor Management Program.
- Manage and maintain the GxP Vendor Management Plan, including risk-based auditing strategy.
- Establish acceptability of Vendors for potential use by SAGE; evaluate strategic partners and suppliers across commercial and development programs (GMP, GLP, GCP, and GPV).
- Devise GxP audit schedule, oversee execution of audit plans and audits, reviews audit reports, and track corrective/preventive actions associated with key vendors in accordance with applicable regulations, guidelines and SAGE SOPs.
- Manage individual consultant auditors to ensure that all audits, resultant reports and other work product are of acceptable quality and in compliance with SAGE requirements.
- Monitor performance/compliance issues identified across Vendors. Elevate systemic problems with appropriate recommendations/solutions to upper management for immediate and long-term resolution across SAGE.
- Ensure reports and corrective actions are developed and completed within timelines mandated in internal procedures related to clinical and bioanalytical suppliers. Provide appropriate risk analysis for key stakeholders to make critical decisions.
- Design and manage a Quality System SharePoint page to collaborate and communicate with cross-functional teams to drive timelines and maintain vendor information, audits and other Quality Systems programs up to date.
- Continually evaluate the strategic approach, drive change in the Quality Systems audit program to meet the changing needs of the organization, regulatory environment and industry best practices.
- Ensure required aspects of the Quality Vendor Management System are trended 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.
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 analyze complex issues 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.
- Minimum 5 years of applicable pharmaceutical drug development/clinical/pharmacovigilance experience.
- Direct experience in conducting and/or leading the following types of audits: Clinical Investigator Sites, External CROs/Vendors, Laboratories (clinical and non-clinical), and CMOs.
- Experience with quality systems and activities at all phases of the Product Lifecycle.
- Experience building relationships and working with external Vendors.
- Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to subject safety and data integrity.
- Knowledgeable of GxP regulations particularly GCP, GLP, GVP and GMP.
- Outstanding communication skills (interpersonal, verbal and written).
- Proven track record of industry success.
- Strong leadership and management 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.