Training Quality System Lead

Proclinical is currently recruiting for a Training Quality System Lead with a pharmaceutical company located in Cambridge, MA. The Global Training Quality Systems Process Support Contractor will be a full-time role with responsibilities to support global learning management system(s) (LMS) and training global processes within the Global quality (GQ) team. The role will also ensure that GxP functions understand regulatory requirements and that training is developed and available to support, maintain and continuously enhance capabilities in the organization to comply with all applicable regulatory requirements. 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.

Job Responsibilities:

• Support the integration of learning systems and processes (L-Shire).
• Create and/or revise global SOPs for core documentation and training processes.
• Project Management and application of ADDIE (Analyze, Design, Develop, Implement and Evaluate) for classroom trainings, eLearnings and learning resources (e.g. videos, computer-based training (CBT), web based training (WBT), LQMs, trainee and trainer manuals, GMP job aids, etc.), including the necessary story boards, outlines, and project plans.
• In collaboration with subject matter experts (SMEs) and Portsmouth Technical and GMP Training Business Partners, develops training materials for use in training courses, with high attention to quality, role-specificity, and engaging learning experience.
• Provide reports and support as needed for audit and inspection activities and as requested by management.
• Manage communication process for global QMS notifications to stakeholders and quality network (weekly emails, process updates, changes and notices for new training). Support other communication initiatives as requested by team leader.
• Support Global Quality Systems team to drive collaboration and sharing of best practices for Training within quality and at sites/regions/business units.
• Leads or is part of cross functional department teams / project teams in the development of training solutions.
• Manage and support deployment of global documents and training content for the Global Quality Organization.
• Support and management of training activities for new global system/programs 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.
• Manage curricula and assignments/enrollments in LMS for global quality personnel.
• Support Global Quality Compliance and Systems with ongoing review of training programs and assignments.
• Conduct usability and user experience testing of learning solutions.
• Serve as point of contact and primary support resource to global quality personnel for LMS related issues.
• Troubleshoots issues with users and Business System Administration community. Investigate problems and provide potential solutions as applicable.
• Provide guidance and train users in LMS where applicable.
• Test SCORM eLearning courses in the LMS as needed.
• Manage cross company access process for integration access to LEADs/Veeva/Saba DMS and LMS systems.
• Support organizational change management and related project communications activities.
• Provide systems administrative support, assigning training and granting permissions and help desk tickets via Service Now / AskIt ticketing system(s) as requested for team back up support.
• Manage SharePoint (intranet) page development, content posting and maintenance.
• Support Global Quality staff with additional tasks as needed.
  
  

Skills and Requirements:

• 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 (ADDIE) and delivery (Adult Learning), 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 LMS administrator.
• SharePoint experience.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134

or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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