Senior System Analyst

Harba Solutions Inc.; Boston (MA); On-site; USD 140,000 - 180,000; Full time

Job summary

A pharmaceutical manufacturing solutions provider is seeking a technical leader to manage IT-to-business relationships for clinical manufacturing operations. This role requires overseeing vendor relationships, ensuring compliance with regulations, and implementing GxP systems. The ideal candidate has over 10 years of IT experience, with a strong focus on project management, adherence to GMP standards, and a background in vendor management in regulated environments.

Qualifications

• 10+ years IT experience in pharmaceutical manufacturing.
• 5+ years in technical leadership roles.
• Proven background in vendor management in regulated environments.
• Strong background in equipment onboarding, validation, and lifecycle management for audit readiness.

Responsibilities

• Own IT-to-business relationships for Clinical Manufacturing operations.
• Manage support models and maintain production environments.
• Lead internal/external teams for implementation and support.
• Oversee change control, deviation management, and CAPA processes using tools like Veeva Vault and TrackWise.
• Collaborate with Process Automation on roles/responsibilities and system ownership.
• Manage vendor relationships for quality and regulatory compliance.
• Author/enforce SOPs for GMP adherence.
• Onboard/validate new equipment and maintain compliance of existing systems.
• Implement new GxP systems (e.g., Data Historian, MES, LIMS) with validation and integration.
• Ensure FDA/GxP compliance, cybersecurity, and policy adherence.
• Partner with IT management for best practices and improvements.

Skills

IT-to-business relationship management

Project management

Vendor management

GMP adherence

Audit readiness

Education

Bachelor’s degree in Computer Science

Tools

Veeva Vault

TrackWise

Data Historian

MES

LIMS

Job description

Responsibilities

• Own IT-to-business relationships for Clinical Manufacturing operations, aligning technology with priorities.
• Manage support models, maintain production environments, and deliver implementation projects on time/budget.
• Lead internal/external teams (onshore/offshore) for implementation and support, ensuring SLA adherence.
• Oversee change control, deviation management, and CAPA processes using tools like Veeva Vault and TrackWise.
• Collaborate with Process Automation on roles/responsibilities and system ownership.
• Manage vendor relationships for quality and regulatory compliance.
• Author/enforce SOPs for GMP adherence.
• Onboard/validate new equipment and maintain compliance of existing systems.
• Implement new GxP systems (e.g., Data Historian, MES, LIMS) with validation and integration.
• Ensure FDA/GxP compliance, cybersecurity, and policy adherence.
• Partner with IT management for best practices and improvements.

Qualifications

• Bachelor’s degree in Computer Science, Information Systems, Engineering, or related field.
• Minimum 10 years’ IT experience in pharmaceutical manufacturing, with at least 5 years in technical leadership.
• Proven vendor management in regulated environments.
• Strong background in equipment onboarding, validation, and lifecycle management for audit readiness.