Senior Manager GMP Systems & PSO Projects

cGMPnow; North Carolina; Presencial; USD 150.000 - 210.000; Jornada completa

Descripción de la vacante

cGMPnow is seeking a Senior Manager in Professional Service Operations to lead staff in Engineering work streams and oversee GMP computerized system implementations across FDA & EU regulated environments.

The role is hands-on with leadership responsibilities, managing scope, schedule, and budgets for capital projects, and coordinating with IT, QA, and clients on system upgrades and new deployments.

Formación

• Bachelor’s degree in an engineering discipline related to GMP/biotech.
• 8+ years as an engineer in GMP life-science environments.
• 5+ years leading project teams and/or managing clients on capital projects.
• 3+ years direct people management experience.
• Experience with design/validation of process control systems (DeltaV, PLCs).
• Experience with Windows-based OT control systems, AD, networking, backups.
• Experience with QC lab systems and associated LIMS.
• Familiar with ISPE Baseline Guides, FDA/EU regulations, cGMPs, risk-based design.
• Excellent leadership, communication, and client-facing skills.
• US work authorization (no sponsorship needed).

Responsabilidades

• Develop and revise CSV project plans, WBS, and schedules.
• Provide project management to integrators/contractors to meet goals.
• Collaborate with IT, System Owner, Engineering, QA to implement systems.
• Define requirements to procure GMP computerized systems compliant with regulations.
• Develop and execute lifecycle documents (URS, Validation Plan, IQ/OQ/PQ, Data Integrity Evaluations).
• Support data integrity implementation and remediation for GMP systems.
• Maintain a controls implementation/data integrity strategy to improve compliance and efficiency.

Conocimientos

Leadership

Client-facing

Communication

Budget management

Project management

Regulatory compliance

Educación

Bachelor's degree in Chemical, Mechanical, Bioengineering, Architecture, Electrical, or related engineering

Herramientas

DeltaV

PLC programming (Allen-Bradley)

HMI development

Active Directory / IT basics

LIMS (LabX, Empower, Softmax Pro)

Descripción del empleo

cGMPnow is seeking a Senior Manager in Professional Service Operations to lead staff in Engineering work streams and oversee GMP computerized system implementations across FDA & EU regulated environments.

The role is hands-on with leadership responsibilities, managing scope, schedule, and budgets for capital projects, and coordinating with IT, QA, and clients on system upgrades and new deployments.