Quality Systems Lead

Alkermes

5d•$141,000 - $146,000

About The Position

Responsibilities Govern owned QMS applications, including harmonization of processes across sites. Responsible for requirements authoring and ongoing maintenance by leading and facilitating meetings/workshops with Site Process Owners and Key Users (Business SMEs). Approve validation deliverables including initial implementation and operational changes. Change ownership, including initiating and managing change through completion. Maintain system in a validated state, including periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with QMS. Lead and manage user forums for ongoing requirements gathering, prioritization, and triaging of issues. Lead and manage ongoing meetings with the vendor/IT as necessary. Report status and issues to governance committees/senior leadership. Communicate milestones and planned changes to user community promoting use of QMS. Responsible for representing owned QMS applications during inspections and explaining compliance. Train management and onboard new users to the system. Ensure Periodic Reviews (PR) are conducted per required frequency and approve PR Reports. Support Quality System Vendor Audits as a Business SME. Support KPI reporting and lead commitment meetings. Manage regular system updates/releases and assess and recommend new features. Ensure key user-related documentation is maintained and kept up-to-date as new functionalities are enabled, created and/or modified. Investigate, escalate, and resolve issues identified on system. Execute/facilitate regression testing associated with system upgrades/project implementation. Participate in user forums/industry groups to garner best practice and represent Alkermes. Identify opportunities for continuous improvement and prioritize and manage associated change to completion. Qualifications Bachelor’s degree in Computer Science, Engineering, or related field and five years of experience implementing and maintaining regulated systems. Experience must include five years each of the following: project management; development of user procedures; and SaaS (Software as a Service Solution)/cloud solutions. Experience must include one year each of the following: TrackWise Digital, ComplianceWire, and Veeva; system testing in a regulated industry; quality systems processes in commercial/clinical pharma/healthcare facility; US FDA, ICH guidelines, and European regulatory requirements; GAMP; and development of CBT (computer-based training) modules. Experience may be gained concurrently. The annual base salary for this position ranges from $141,000 to $146,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here . #LI-DNI

Requirements

Bachelor’s degree in Computer Science, Engineering, or related field and five years of experience implementing and maintaining regulated systems.
Experience must include five years each of the following: project management; development of user procedures; and SaaS (Software as a Service Solution)/cloud solutions.
Experience must include one year each of the following: TrackWise Digital, ComplianceWire, and Veeva; system testing in a regulated industry; quality systems processes in commercial/clinical pharma/healthcare facility; US FDA, ICH guidelines, and European regulatory requirements; GAMP; and development of CBT (computer-based training) modules.

Responsibilities

Govern owned QMS applications, including harmonization of processes across sites.
Responsible for requirements authoring and ongoing maintenance by leading and facilitating meetings/workshops with Site Process Owners and Key Users (Business SMEs).
Approve validation deliverables including initial implementation and operational changes.
Change ownership, including initiating and managing change through completion.
Maintain system in a validated state, including periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with QMS.
Lead and manage user forums for ongoing requirements gathering, prioritization, and triaging of issues.
Lead and manage ongoing meetings with the vendor/IT as necessary.
Report status and issues to governance committees/senior leadership.
Communicate milestones and planned changes to user community promoting use of QMS.
Responsible for representing owned QMS applications during inspections and explaining compliance.
Train management and onboard new users to the system.
Ensure Periodic Reviews (PR) are conducted per required frequency and approve PR Reports.
Support Quality System Vendor Audits as a Business SME.
Support KPI reporting and lead commitment meetings.
Manage regular system updates/releases and assess and recommend new features.
Ensure key user-related documentation is maintained and kept up-to-date as new functionalities are enabled, created and/or modified.
Investigate, escalate, and resolve issues identified on system.
Execute/facilitate regression testing associated with system upgrades/project implementation.
Participate in user forums/industry groups to garner best practice and represent Alkermes.
Identify opportunities for continuous improvement and prioritize and manage associated change to completion.