Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
The following position is for Alkermes, Inc.
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 & 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/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 SMEsParticipate and sometimes lead user forums or working team meetings togather 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/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/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
- 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
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic inf ormation, veteran status, military status, application for military service or any other class protected by 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.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.