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
Bachelor’s degree in computer science, Life Sciences, Engineering, or related field, with 9+ years of progressive experience in Digital Quality within a GxP-regulated pharmaceutical or biotech environment (master’s degree with 7+ years also considered)
Highly Quality minded with experience supporting computer system validation activities in a GxP-regulated environment is preferred. Strong quality systems, compliance, and data integrity experience is required, including experience with Enterprise Quality Systems (e.g., LMS, Veeva DMS, TrackWise/TrackWise Digital) and paperless validation platforms such as ValGenesis
Knowledge of GxP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11, Part 312, Part 314, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9, and Q10
Excellent interpersonal, leadership, collaborative, communication (written and verbal), and time-management skills are essential
Proven track record in current and previous roles. Results and Performance driven
Strong leadership skills and ability to work within cross-functional teams. Experience leading teams is essential
Flexibility and adaptability to changing needs and requirements
The annual base salary for this position ranges from $110,000 to $126,000. 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
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
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