General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for quality Document Management and Training.
Roles and Responsibilities
- Responsible for supporting and managing the electronic Document Management System (eDMS) in compliance to regulatory requirements.
- Manage controlled document lifecycle activities. Including, but not limited to issuing Change request numbers, QC and prep documents for approval, manage periodic review, maintain storage and inventory of Quality documents and records.
- Responsible for development, deployment and maintenance of effective and efficient procedures surrounding document control and records management.
- Effectively monitor training and documentation at a global level and ensure continuous improvement.
- Provide support during internal and external audits related to Regulatory and internal audits for
- Responsible for the development, deployment and maintenance of the corporate records management program and records retention schedule.
- Additional responsibilities assigned by manager.
- Develop training curricula for employee functions for GCP/GLP/GMP processes
- Conduct instructor led training programs including the " why" for presenting complex issues to a diverse audience. Assess training effectiveness to ensure transfer of skills and knowledge into associate work behavior
- Lead the creation, review and update of a Leaning Management systems: for programs, content, while working with internal stakeholders and systems experts to track and deploy eLearning as appropriate.
- Develop and present formal recommendations for enhancements, upgrades and business process changes related to Documentation and Leaning Management Systems.
- Establish and deploy timely metrics for Documentation and Training Management leading to action plans for Quality Council/meetings for continuous improvement.
- Use expertise in the latest learning and development methods and adult learning theory to shape and design learning programs through networking and benchmark, identify best industry practices
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 and ability to develop relationships with key stakeholders. Ability to communicate issues in a simple way and to develop plans to resolve issues and risks.
- B.S./B.A. or science degree.
- 10+ years Quality Assurance experience including 3-5 years’ experience in Documentation/Training (eDMS and eLMS systems)
- Possess in-depth knowledge of GCP/GLP/GMP regulations, principles, concepts, industry practices and standards
- Strong knowledge of quality assurance processes and procedures including sterile/solid dosage manufacturing
- Extensive knowledge of instructional design theory, adult learning principles and methods for curriculum design.
- Excellent knowledge in MS Office, Visio, MS Project, eLMS, EDMS systems and database software
- Excellent interpersonal, problem solving, risk analysis and negotiation skills.
- Effective organization, communication, and team orientation skill
- Ability to coordinate timelines with internal customers and external clients and vendor
- Strong team player that has a customer service approach and is solution oriente
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendor
- Possesses strong written and verbal communication 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