GMP QC Systems Lead (CSV & Validation)

JobDiva, Inc.; Annapolis (MD); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC seeks an experienced lead to drive GMP QC systems implementation and validation across pharma projects. You’ll coordinate configuration, data migration, deployment, and stakeholder engagement to ensure on-time delivery.

Responsibilities include kick-off sessions, risk-based testing, IQ/OQ/PQ execution, and keeping QA, IT, and vendors aligned with GxP and data integrity standards for a successful go-live.

Qualifications

• 8+ years in pharmaceutical/biotech or regulated GMP environments with strong QC/Lab systems implementation and validation.
• Experience with CSV, CSA, GAMP5, and GxP regulations; hands-on IQ/OQ/PQ, risk assessments, testing and compliance activities.
• Experience managing system integrations, data migration and cross-functional project delivery.

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 adherence.
• Prepare status reports and ensure transparent progress tracking; support CSV/CSA and validation activities, including IQ/OQ/PQ execution and documentation.
• Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance; ensure adherence to GxP, Data Integrity, and Roche validation standards.

Skills

GMP

QC/Lab systems

CSV

GAMP5

GxP regulations

IQ/OQ/PQ

Risk assessments

Agile/Scrum

Stakeholder management

Documentation

Tools

LIMS

SDMS

Empower

SoftMax Pro

QuantStudio

LabX

Job description

Roles & 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 project progress, risks, timelines, quality, and budget adherence.
• Prepare status reports and ensure transparent progress tracking. Support CSV/CSA and validation activities, including IQ/OQ/PQ execution and documentation. Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance.
• Ensure adherence to GxP, Data Integrity, and Roche validation standards. Support system acceptance, release readiness, and go-live activities.

Requirements:

• 8+ years of experience in pharmaceutical, biotech, or regulated GMP environments. Strong experience with QC/Laboratory systems implementation and validation. Knowledge of Computer System Validation (CSV), CSA, GAMP5, and GxP regulations.Hands-on experience supporting IQ/OQ/PQ, risk assessments, testing, and compliance activities.
• Experience managing system integrations, data migration, and cross-functional project delivery.
• Familiarity with laboratory platforms such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar systems.Strong stakeholder management, Agile/Scrum, and project coordination skills.Excellent communication and documentation capabilities