Lead Computer Systems Validation Engineer I (Clinical & R&D)

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.

• 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

• 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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