Senior Systems Analyst III IT- Clinical Manufacturing

Senior Systems Analyst III, Clinical Manufacturing

Join to apply for the Senior Systems Analyst III, Clinical Manufacturing role at Alkermes.

Location:

Waltham, MA (Hybrid Office Schedule).

The IT Senior System Analyst III for Clinical Manufacturing Suite will lead all technology implementation, production support, and maintenance activities within the Clinical Manufacturing Suite, ensuring systems are reliable, secure, and compliant with GMP and GxP requirements. This position will be responsible for authoring and enforcing SOPs to meet GMP guidelines, onboarding and validating new equipment, maintaining compliance of existing systems, and driving the implementation of new IT GxP solutions such as Data Historian and LIMS.

Partnering closely with CMC, quality, and regulatory teams, the IT Senior System Analyst III ensures alignment with FDA and global regulatory standards while fostering continuous improvement, operational excellence, and strong collaboration across the organization. The role requires deep knowledge of pharmaceutical manufacturing processes, regulatory compliance, and IT systems integration to ensure reliable, secure, and compliant operations.

• Own and foster the IT-to-business relationship for Clinical Manufacturing operations, ensuring alignment of technology strategy with manufacturing leadership priorities.
• Define and manage a support and operating model for the Clinical Manufacturing Suite, maintaining application production environments to quality standards and delivering high-value implementation projects on time and on budget.
• Lead a team of internal and external, onshore and offshore IT professionals to execute implementation and support activities, ensuring SLA adherence and customer satisfaction.
• Provide oversight and expertise in Clinical Manufacturing change control, deviation management, and CAPA processes to ensure IT systems support regulatory and quality expectations; and proficient in tools like Veeva Vault, Track Wise Digital.
• Work closely with the Process Automation (PA) group to define clear roles and responsibilities between IT and PA, ensuring seamless collaboration and system ownership across both functions.
• Manage partner/vendor relationships, ensuring external service providers deliver quality and performance according to service levels and regulatory requirements.
• Develop, write, and enforce Standard Operating Procedures (SOPs) to ensure adherence to GMP guidelines across all IT-supported manufacturing processes.
• Oversee onboarding of new equipment into the Clinical Manufacturing Suite, ensuring systems are validated, compliant, and maintained according to regulatory standards.
• Maintain compliance of all existing equipment and IT systems, ensuring continuous alignment with GMP and GxP requirements.
• Lead implementation of new IT GxP systems within the suite (e.g., Data Historian, MES, LIMS), ensuring proper validation, integration, and ongoing support.
• Ensure adherence to regulatory requirements (FDA, GxP), cybersecurity standards, and departmental policies, practices, and SOPs.
• Partner with global and local IT management to align best practices across Alkermes, introducing process improvements and leveraging industry learnings.

Basic Qualifications

• Bachelor’s degree in computer science, Information Systems, Engineering, or related field.
• Minimum of ten (10) years’ IT experience supporting pharmaceutical manufacturing suite or with at least 5 years in technical leadership roles.
• Proven experience managing IT vendor relationships and service providers in a regulated environment.
• Demonstrated expertise in GMP and GxP compliance, including authoring, maintaining, and enforcing SOPs for IT systems supporting manufacturing operations.
• Strong background in equipment onboarding, validation, and lifecycle management to ensure systems remain compliant and audit‑ready.

Preferred Qualifications

• Hands‑on experience with ERP, Data Historian, Laboratory Information Management Systems (LIMS), and other GxP manufacturing support technologies.
• Deep understanding of system validation, qualification, and change control processes in pharmaceutical/biotech…