QC Process & Compliance Specialist

Sanofi Inc.; Bedford; On-site; GBP 51,000 - 69,000; Full time

Job summary

Sanofi Waterford site seeks a QC Business Process Specialist to drive GMP-compliant laboratory processes. You will focus on SOP/procedure management, deviations and CAPA handling, and support LIMS/digital systems to ensure alignment with regulatory requirements.

The role emphasizes continuous improvement, standardization, and training across the QC Lab Team, contributing to efficient, compliant operations in a fast-paced biopharma environment.

Qualifications

• Experience with pharmaceutical regulations (FDA, EMA, ICH).
• Experience with internal audits and regulatory inspections.
• Knowledge of GMP, deviation and CAPA processes.

Responsibilities

• Develop and maintain an effective compliance program.
• Ensure operations meet regulatory requirements and standards.
• Provide training and guidance on compliance topics.
• Maintain and ensure accuracy of compliance documentation.
• Identify compliance risks and help mitigate them.
• Support investigation and reporting of compliance incidents.
• Manage CAPA to prevent recurrence.

Skills

Strong communication

Attention to detail

Analytical skills

Project management

Tools

LIMS

Job description

Sanofi Waterford site seeks a QC Business Process Specialist to drive GMP-compliant laboratory processes. You will focus on SOP/procedure management, deviations and CAPA handling, and support LIMS/digital systems to ensure alignment with regulatory requirements.

The role emphasizes continuous improvement, standardization, and training across the QC Lab Team, contributing to efficient, compliant operations in a fast-paced biopharma environment.