Quality Systems Specialist II
KEY AREAS OF JOB ACCOUNTABILITY:
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.
Position details:
- 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, TrackWise, 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 plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com .
Degree LevelBachelor's Degree