QC CAPA & Compliance Specialist

Sanofi Inc.; Chester; On-site; GBP 47,000 - 64,000; Full time

Job summary

Sanofi Waterford seeks a QC Business Process Specialist to drive compliance across the QC lab, focusing on SOP management, CAPA handling, and GMP alignment with regulatory standards. The role supports LIMS and digital systems to ensure efficient, compliant microbiology operations.

The candidate will contribute to regulatory readiness, training, and documentation, maintaining robust controls in a fast-paced biopharma environment.

Qualifications

• Experience ensuring compliance with pharmaceutical regulations and standards (FDA/EMA/ICH).
• Experience leading internal audits and regulatory inspections, including prep and follow-up.
• Strong ability to interpret regulations and translate into practical processes.

Responsibilities

• Develop and maintain an effective compliance program.
• Ensure operations meet regulatory requirements and international standards.
• Provide training and guidance on compliance topics to employees.
• Maintain accurate compliance documentation and records.
• Identify compliance risks and help develop mitigation strategies.
• Support investigation and reporting of compliance incidents.
• Manage CAPA to address incidents and prevent recurrence.

Skills

GxP Compliance

CAPA

SOP Management

Audit readiness

LIMS

Tools

LIMS systems

Job description

Sanofi Waterford seeks a QC Business Process Specialist to drive compliance across the QC lab, focusing on SOP management, CAPA handling, and GMP alignment with regulatory standards. The role supports LIMS and digital systems to ensure efficient, compliant microbiology operations.

The candidate will contribute to regulatory readiness, training, and documentation, maintaining robust controls in a fast-paced biopharma environment.