Description KEY AREAS OF JOB ACCOUNTABILITY: Provides process and technical leadership and assumes accountability for Quality System applications as assigned and will be ultimately responsible for ensuring that the quality system is compliant, and its operations are fit for intended use in accordance with applicable global procedures. Spearhead the improvement and management of DMS/QMS applications, as assigned, including harmonization of processes across sites. Responsible for defining the directional course of quality systems implementation and upgrade projects, ensuring comprehensive consultation and communication with impacted teams, individuals, and stakeholders. Responsible for requirements – authoring and on-going maintenance by leading and facilitating meeting/workshops with Site Process Owners and Key Users (Business SMEs) Lead development of and approve validation deliverables as a Global Process Owner as assigned– initial implementation and operational changes. Change Owner role – initiating and managing change through completion. Maintain system in a validated state – periodic user access review, ongoing change management, business administration, deviations/CAPAs associated with DMS/QMS. Lead and manage user forums – for ongoing requirements gathering, prioritization and triage issues. Lead and manage ongoing meetings with the vendor/IT where required. Demonstrate proficiency in writing or reviewing project documentation, SOPs and all forms of internal customer facing communication with minimal consultation. Demonstrate an effective and flexible communication style when engaging with the team and cross-functionally. Report status and issues to all levels of governance as senior leadership as assigned. Responsible for representing DMS/QMS applications during inspections and speaking to compliance. Training management and onboarding of new users to the system. Responsible for ensuring Periodic Reviews (PR) are conducted per required frequency; support Periodic Review process and approve PR Reports. Support Quality System Vendor Audits as a Business SME, as needed. Support KPI reporting and lead commitment meetings. Manage regular system updates/ releases, provide assessment of and recommendations regarding new features. Ensure key user-related documentation is maintained and kept up-to-date as new functionalities are enabled, created and/or modified. Investigation, escalation and resolution of issues identified. Execution/ facilitation of regression testing associated with system upgrades/ project implementation. Participation in user forums/ industry groups to garner best practice and represent Alkermes. Identifying opportunities for continuous improvement, prioritize and manage associated change to completion. May be expected to manage temporary employees, as required, for system/process related projects. ACADEMIC/TECHNICAL QUALIFICATIONS: Bachelor’s degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality orientation. Minimum of 8-10 years of experience in a high volume commercial / clinical pharma / healthcare facility. Proven experience and expertise in implementing and maintaining Quality Systems with solid understanding of Quality System processes. Thorough understanding and working knowledge of US FDA, and European regulatory requirements, GAMP and the ability to determine phase appropriate requirements. Excellent knowledge of Regulatory Compliance and ICH Guidelines. Established track record with evidence of people management experience, project management, problem solving, collaborative, leadership and communication skills. The annual base salary for this position ranges from $126,000 to $137,000. 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-RS1 #LI-Hybrid