CSV Lead: GxP Compliance & Digital Validation

Roquette Frères S.A.; United States; Remote; GBP 68,000 - 90,000; Full time

Benefits offered by this job

Performance bonus

Retirement contribution

Paid time off

Holidays

Tuition reimbursement

Wellness programs

Job summary

Roquette is seeking a CSV specialist to join our global Quality team, driving validation and compliance for GxP systems across sites.

You will own regulatory-aligned validation activities, maintain Master Plans, and support internal and health authority inspections.

Primarily office-based role with global collaboration, travel as needed, and opportunities for professional growth within Roquette.

Qualifications

• Minimum 3–5 years' CSV or digital quality experience in regulated environments.
• Experience with validation lifecycle deliverables and audits.
• Knowledge of lab systems like LIMS and CDS.
• Experience supporting regulatory inspections is preferred.

Responsibilities

• Own and apply CSV framework for GxP apps and infrastructure across Roquette.
• Ensure compliance with EU GMP Annex 11/15, FDA 21 CFR Part 11, and GAMP 5.
• Embed quality requirements from project initiation through retirement.
• Maintain regulatory watch and translate into practical standards.
• Promote validation practices for Agile, SaaS, and cloud models.

Skills

GxP knowledge

CSV

Quality Assurance

Regulatory inspections

ERP/LIMS experience

Education

Master's degree

Tools

LIMS

CDS

eQMS

ERP

GAMP 5

Job description

Roquette is seeking a CSV specialist to join our global Quality team, driving validation and compliance for GxP systems across sites.

You will own regulatory-aligned validation activities, maintain Master Plans, and support internal and health authority inspections.

Primarily office-based role with global collaboration, travel as needed, and opportunities for professional growth within Roquette.