Senior Systems Analyst

Job Requirements

• 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.

Job 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.
• Expertise in GMP/GxP compliance, including SOP authoring/enforcing.
• Strong background in equipment onboarding, validation, and lifecycle management for audit readiness.