Quality Systems Manager II
Job Title: Quality Systems Manager II
Location: Cambridge, MA
The Global Quality Systems Process Owners group oversees the company's Global Quality Management Systems for GxP Documentation, Training, Events, CAPAs and Change Control. The Global Quality Systems Process Support Contractor will be a full-time role with responsibilities to support companies 's global document management system (DMS) and learning management system (LMS) and documentation and training global processes within the quality management system (QMS). Tasks will include daily operational and maintenance activities related to the business processes executed in these systems for Global Quality, end user support, integration support and contributions to improvement of existing process.
Responsibilities Document and Training Management 1. Create and/or revise global SOPs for core documentation and training processes. 2. Design training content and deliver training programs for Global Quality as needed. 3. Provide reports and support as needed for audit and inspection activities and as requested by management. 4. Manage communication process for global QMS notifications to stakeholders and quality network (weekly emails, process updates, changes and notices for new documentation and training). Support other communication initiatives as requested by team leader. 5. Support Global Quality Systems team to drive collaboration and sharing of best practices for Documentation and Training within quality and at sites/regions/business units.
Training and Documentation Administration 1. Manage and support deployment of global documents and training content for the Global Quality Organization 2. Manage documentation and training activities for new global system implementations. This will include processing documents in the DMS, processing training content in the DMS and creating and maintaining learning modules and curricula in the LMS. 3. Manage assignments/enrollments in LMS for global quality personnel. 4. Support Global Quality Compliance and Systems with ongoing review of training programs and assignments.
System Support 1. Serve as point of contact and primary support resource to global quality personnel for DMS and LMS related issues. 2. Troubleshoots issues with users and Business system Administration community. Investigate problems and provide potential solutions as applicable. 3. Provide guidance and train users in quality systems software applications where applicable. 4. Test SCORM eLearning courses in the LMS as needed. 5. Manage cross company access process for integration access to LEADs/Veeva/Saba DMS and LMS systems. 6. Support organizational change management and related project communications activities 7. Provide systems administrative support, assigning training and granting permissions and help desk tickets via Service now ticketing system as requested for team back up support. 8. Manage SharePoint (intranet) page development, content posting and maintenance 9. Support Global Quality Systems staff with additional tasks as needed
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: * Bachelor's degree with experience in pharmaceutical/ biotechnology industry, or equivalent (5-10 years). Experience may be substituted for degree. * Strong working knowledge of the operation of pharmaceutical quality systems and applicable global regulations. * Strong knowledge in training design and delivery, preferably in quality or quality systems. * Experience with Documentation and Training activities in a pharmaceutical/biotechnology (GxP) company. * Prior experience using validated Documentation and Training management systems (such as Veeva, QUMAS, Plateau, Sum Total, SABA, NetDimensions, ISOTrain) with clear potential for full proficiency as a DMS and LMS administrator. * SharePoint experience. * Ability to network and interact effectively with colleagues globally, and across functions and cultures. * Strong written and communication skills. * Proactive, self-directed working style
Sthree US is acting as an Employment Business in relation to this vacancy.