- Provide support for computer system validation activities across Quality, Regulatory, and R&D systems, including ensuring projects comply with applicable regulations, internal policies, and SOPs
- Represent CSV in project teams and collaborate with stakeholders, as applicable. Measure and report project execution progress
- Determine levels of importance or risk to be assigned to elements under review - to ensure validation efforts are directed at the systems that have the potential to impact product quality, efficacy, and data integrity using a variety of tools including GAMP 5 and Quality Risk Management
- Support the development, review, approval, and execution of validation-related documentation throughout the system lifecycle
- Conduct and approve risk assessments in line with the company Quality Risk Management policy
- Present a coherent and clear picture of validation effort to any reviewer or auditor, providing confidence in the installed computerized system
- Understand the science and areas of technical knowledge that underpin area of focus and must be able to apply this knowledge in the development of validation approach and in the presentation, documentation, and review of outcome
- Exposure to Validation of AI and AI validation methodology
- Contribute effectively to GxP compliance maintenance through monitoring, review, assessment, and qualification activities, including Change Control, Deviations, CAPAs, Periodic Reviews, Access Reviews, and SOP updates, along with attendance in forums where such KPIs are reviewed
- Support compliance of computerized systems with current corporate global computerized validation policies and Digital Quality expectations
- Support the creation and maintenance of computer system validation templates in ValGenesis and general job aids that are relevant and available to applicable users
- Support regulatory inspections and internal audits by providing CSV-related responses and support, as applicable, to inspectors and auditors
- Serve as a CSV-related supplier or third-party vendor audit activities, including management of corrective actions to closure as needed
- Provide relevant training to key project personnel before computerized system validation activities begin, as applicable to the Digital Quality lead role
- Lead and/or assist training content development and delivery related to validation methodology
- (As required) Move to other areas of activity applying skills in logic and scientific method while quickly assimilating knowledge and contributing to delivery
- Represent in cross-functional forums and follow up on any resulting action items in a timely manner
- Understand best industry practice, current developments, and opportunities arising for the organization
- Actively participate in Professional/Industry groups to learn, to influence, and to represent the organization
This position provides leadership and accountability for Digital Quality across the organization's Quality, Regulatory, and R&D systems landscape, with responsibility for supporting computer system validation activities in alignment with applicable regulatory expectations, internal procedures, and data integrity requirements. The role is focused on ensuring GxP computerized systems are implemented, maintained, and governed in a compliant, risk-based, and inspection-ready manner throughout the system lifecycle.
Why join Team Alkermes?
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 BioPharma 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.