Germer International - Pharmaceutical Recruiting · 3 hours ago
Senior IT Systems Analyst
Greater Boston
Full-time
Hybrid
Senior Level, Lead/Staff
$155K/yr - $175K/yr
10+ years expGermer International is a global leader in the development and manufacturing of branded commercial OSD and injectables, seeking a Senior IT Systems Analyst for their new clinical, pilot-plant facility. The role involves managing IT systems and ensuring compliance with GMP and GxP requirements while leading technology implementation and support activities within the Clinical Manufacturing Suite.
BiotechnologyPharmaceuticalRecruitingStaffing Agency
Hiring Manager
Jessica Gerber
Responsibilities
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, TrackWise 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 Company, introducing process improvements and leveraging industry learnings
Qualification
Required
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
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 environments
Excellent verbal and written communication and presentation skills, with the ability to interact professionally with executives, managers, and subject matter experts
Self-starter with ability to multitask and manage simultaneous work requests across departments and cross-functional teams
Ability to influence, motivate, and drive alignment among project stakeholders and internal/external team members toward mutually beneficial outcomes
Ability to work a weekly hybrid office schedule
Company
Germer International - Pharmaceutical Recruiting
Welcome to Germer International! We're a Life Sciences search & placement firm that focuses on building long-term partnerships with small and mid-sized companies across the country.
11-50 employees
Funding
Current Stage
Early StageRecent News
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