Quality Systems Specialist II

The Quality System Specialist II, under the direction of the QS&C management team, will be responsible to support and continuously improve the global DMS, LMS & QMS systems, and their operations, as assigned, to ensure that they are compliant and fit for intended use in accordance with applicable global SOPs.

• Collaborate with global, site and departmental subject matter experts and site process leads as appropriate to support governance of DMS/LMS/QMS applications, including harmonization of processes across sites
• Assist in gathering requirements for improvements and ongoing maintenance by participating in meeting/workshops with Site Process Owners and business SME. Participate and sometimes lead user forums or working team meetings to gather ongoing requirements and prioritize and triage issues
• Provide project and report statuses to manager/ working teams as needed
• Provide guidance to Subject Matter Experts and Site Process Leads on system functionality as well as supporting quality system processes
• Support the development and design of evolving or future Quality Systems
• Initiate and manage change controls, with associated documentation requirements, to completion
• Ensure system is maintained in a validated state by participating, and when appropriate leading, periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with DMS/LMS/QMS
• Support and when appropriate lead investigation, escalation, and resolution of issues identified on the system including initiation and owning of related deviations, CAPAs and Change Controls as needed
• Support validation activities as requested; this includes but is not limited to authoring/execution/ facilitation of UAT/regression testing associated with system upgrades/ project implementation
• Support manager with ongoing communication from vendor/IT where required
• Communicate milestones and planned changes to the user community; promote use of DMS/LMS/QMS
• Provide customer support through system and training management and onboarding of new users
• Support Quality System Vendor Audits as a Business SME, as needed
• Generate metrics to support quality systems
• Support regular system updates/ releases and provide assessment of and recommendations regarding new features
• Author and maintain key user-related documentation and ensure it is kept up to date as new functionalities are enabled, created and/or modified

ACADEMIC/TECHNICAL

QUALIFICATIONS:

• Bachelor’s degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality background
• Minimum of 3-6 years of experience in a high volume commercial / clinical pharma / healthcare facility
• Proficient in MS Word, Excel, and Quality System processes. Experience maintaining Quality Systems processes for Veeva, Track Wise, and Compliance Wire experience a plus
• Understanding and working knowledge of US FDA and European regulatory requirements and GAMP, and the ability to determine phase appropriate requirements
• Knowledge of Regulatory Compliance and ICH Guidelines

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Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in Bio Pharma by Fortune Magazine.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Alkermes is an E-Verify employer.

• Job Identification 13855
• Job Category Quality
• Posting Date 02/24/2026, 07:01 PM
• Degree Level Trade or Technical School Diploma