The Quality Assurance project manager leads QA Ops teams on multiple process improvement projects from inception through completion, while adhering to project scope, schedule, quality and budget. The project manager must possess strong communication skills and must work with both Quality and business partners across the organization in a collaborative way. In this role, the incumbent will work with the QA Operation Lead to identify process improvement initiatives within the QA group. Working across boundaries to ensure project work complies with established practices, policies, and processes. Project issues and risks must be identified and tracked, and plans to resolve these issues must be developed and solutions executed.
Reporting to the Quality Assurance Operations Lead, this position is accountable for the successful and timely completion of projects within Quality Assurance including:
* Implementation of DMS and QMS systems
* Manage integration between the LMS and DMS systems, as applicable
* KPI Management and Reporting
* Process Improvements
* Lean Excellence/Standardization of processes including issue identification and resolution for processes managed by the QA Ops group
* Document Retention and File Room Management
* Maintenance of the Risk Register
* Management of the SharePoint Quality Site
Describe the essential daily job functions and include% of time spent on each .
Job Function and Description
* Working with the Doc Control & Quality Systems, to implement and administer new electronic systems and solutions.
* Responsible for successful strategic project execution & delivery, team management, prioritization, resource planning, execution tools, training and monthly reporting as they apply to assigned projects and new and improved processes.
* Work to standardize processes within the QA Ops organization as well as helping the Manufacturing areas standardize their processes.
* Responsible for working with QA Ops Lead to identify process improvement initiatives within the QA Ops group.
* Responsible for scheduling and leading cross functional meetings to discuss and document review of metrics and other Quality metrics, issuing meeting minutes and following up on action items.
* Maintain the Document Retention program, management of the SharePoint sites, Scanning critical documents and GMP file room.
* Provide input and guidance, and may advise the Lead in the overall systems' strategy.
* Work in partnership with cross functional groups to foster partnerships with customers/stakeholders/sponsors. Chairs project team meetings and is responsible for coordinating moderately complex team operations and communications.
* Directs project communications and ensures that all project customers are fully informed and knowledgeable of project activities and their status.
* Collaborates with functional leaders to ensure that functional area resources are sufficient to achieve project goals and objectives.
* Leads the design, implementation, and update of project plans, which form the operational basis for the project team. Ensures that project plans optimize the integration of timing, scope and resources.