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GMP Consultant

Diverse Lynx, LLC

DE

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JOB DETAILS
SKILLS
Agile Programming Methodologies, Biotech and Pharmaceutical, Budgeting, Communication Skills, Computer Systems, Consulting, Cross-Functional, Data Migration, Data Quality, Documentation, GMP (Good Manufacturing Practices), GxP, Laboratory Information Management System (LIMS), Laboratory Systems, Lynx, Maintain Compliance, Organizational Skills, Process Validation, Project Execution, Project Tracking, Project/Program Coordination, Quality Assurance, Quality Control, Regulations, Reporting Skills, Risk Analysis, Scientific Data Management System (SDMS), Scrum Project Management and Software Development, Status Reports, System Integration (SI), System Validation, Systems Administration/Management, Testing
LOCATION
DE
POSTED
7 days ago

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. Required Skills & Experience8+ 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.

Key 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. Required Skills & Experience8+ 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

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.

About the Company

D

Diverse Lynx, LLC