General Scope and Summary:
SAGE Therapeutics is searching for a Quality Systems, Training Manager. The Quality Systems Training Manager is responsible for developing and maintaining quality (GxP) training program. Lead the development and implementation of GxP training and schedules on behalf of Sage. Collaborate with Department leads to identify GxP training needs. Provide leadership and management of the training program to ensure that the appropriate training activities are developed and implemented in line with Quality System objectives.
Roles and Responsibilities:
- Develop, manage and communicate Sage’s GxP training requirements and initiatives.
- Serve as Sage’s System Owner and Business Administrator of the Learning Management System (LMS).
- Provide technical expertise and innovative ideas to continuously improve upon quality training programs and advance training effectiveness.
- Provide monthly training metrics to monitor the health and effectiveness of the Training Program.
- Provide training instruction and deliver courses.
- Special projects as assigned.
- Drives cross-functional resolutions.
Experience, Education and Specialized Knowledge and Skills:
- Bachelors’ and/or Masters’ degree in scientific discipline.
- Minimum 5+ years of experience with biotech, pharmaceutical or life sciences company in a training role or prior position in education
- Technical understanding of biopharmaceutical production and knowledge of US and EU cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements is necessary
- Ability to work in matrixed environment and with key stakeholders to drive high quality decisions
- Excellent facilitation, presentation, instructor skills
- Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
- Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
- Project management experience.
- Experience with regulatory inspections and audits.
- ComplianceWire/ELMS experience preferred