Senior QC Systems Lead: GMP, CSV & Validation

Creative Solutions Services, LLC; San Diego (CA); On-site; USD 150,000 - 185,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a senior professional to lead the implementation and integration of GMP QC systems in a regulated environment. You will coordinate system configuration, data migration, deployment, and stakeholder engagement across QA, IT, and vendors.

The role requires strong experience in QC/Lab systems validation, CSV/CSA, GAMP5, and DQ/IQ/OQ/PQ activities. You will drive kick-off sessions, manage risks, timelines, and ensure regulatory compliance throughout the

Qualifications

• 8+ years of experience in pharmaceutical, biotech, or regulated GMP environments.
• Strong experience with QC/Laboratory systems implementation and validation; known CSV, CSA, GAMP5, and GxP regulations.

Responsibilities

• Lead implementation and integration activities for GMP QC systems.
• Coordinate system configuration, data migration, deployment, and stakeholder engagement.
• Conduct implementation kick-off sessions and drive project execution; monitor progress, risks, timelines, quality, and budget.

Skills

GxP knowledge

CSV compliance

Agile/Scrum

Stakeholder management

Documentation

Tools

LIMS

SDMS

Empower

SoftMax Pro

QuantStudio

LabX

Job description

Creative Solutions Services, LLC is seeking a senior professional to lead the implementation and integration of GMP QC systems in a regulated environment. You will coordinate system configuration, data migration, deployment, and stakeholder engagement across QA, IT, and vendors.

The role requires strong experience in QC/Lab systems validation, CSV/CSA, GAMP5, and DQ/IQ/OQ/PQ activities. You will drive kick-off sessions, manage risks, timelines, and ensure regulatory compliance throughout the