Quality Systems Manager II

Highly Competitive
  1. Permanent
  2. Good Distribution Practice (GDP)
Cambridge, Massachusetts
Posting date: 05 Mar 2019

ProClinical is advertising a vacancy for a Quality Systems Manager II position with a leading global pharmaceutical company that specialises in multiple therapy areas. They are currently looking to recruit the Quality Systems Manager to work in their Massachusetts office. This is an excellent opportunity to work with a company that prides itself on its superb pipeline of treatments for diabetes, cancer, and asthma.

The Quality Systems Manager II will support the business operational activities related to the implementation of these global systems within the global organization. They will oversee the global training administration in the LMS for global quality content and users and assist with the design and delivery of some training, as well as contributing to the ongoing operation and improvement of the Global Training Program.

The Quality Systems Manager II will coordinate the development of training plans, learning programs, and course materials with project teams and/or external vendors where applicable. They will manage the delivery of translations for GxP documents and training materials and administer in the Global electronic document and Learning Management System (DMS/LMS).

Job Responsibilities:

  • Acting as primary contact and support to the assigned departments for LMS and training related issues; fielding questions and issues from functional staff.
  • Coordinating training assignments for employees in global quality.
  • Performing training needs assessment with line managers for new hires.
  • Working with line managers to develop/revise position specific training requirements.
  • Periodically reviewing requirements to identify areas of inconsistency.
  • Assigning training to employees and ensuring that requirements are updated.
  • Identifying training needs to be delivered across functions.
  • Documenting changes to learning plans.
  • Identifying new training opportunities and requirements.
  • Completing administrative tasks, such as filing and data entry.
  • Providing reports and support as needed for audits and inspection activities.
  • Creating and managing course items in the LMS system.
  • Creating and managing online content.
  • Creating and managing programs.
  • Testing SCORM eLearning courses in the LMS as needed.
  • Running reports upon request and sending learning needs reports to line managers.
  • Assisting Global Quality Compliance and Systems with ongoing review of training programs and assignments.
  • Providing reports and triage support for audit/inspection activities.
  • Assisting and training employees in their use of the LMS, as needed.
  • Answering help desk tickets and responding to employee questions and requests; troubleshooting issues.
  • Working collaboratively to identify plans for resolving issues and identifying steps to prevent potential problems.
  • Providing training to new LMS administrators on the functionality and processes surrounding the enterprise system.
  • Providing support to other LMS administrators in all areas of the company and providing coverage during vacations or periods of leave.
  • Facilitating the development of training plans and learning programs for global projects.
  • Managing the development, review, and approval of training content with project stakeholders and external vendors.
  • Coordinating learning and documentation workstream activities and ensuring delivery of training content for LMS administrations to support project needs and timeline.
  • Managing workflows in the Document Management System.
  • Managing delivery, reviewing, and administering of translations for applicable GxP documents and training content.
  • Serving as backup Business System Administrator in the LMS.
  • Participating in continuous improvement projects.

Skills and Requirements:

  • A Bachelor's or Associate's degree with at least four years of experience in pharmaceuticals; equivalent experience will also be considered.
  • Prior experience using validated training management systems, such as Plateau, Sum Total, Blackboard, or SABA, with clear potential for full proficiency as an LMS administrator.
  • Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

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 Kevin Cassini at +1 215 531 5288 or upload your CV 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.