QC Compliance & Process Improvement Specialist

Sanofi Inc.; Chesterfield; On-site; GBP 51,000 - 67,000; Full time

Benefits offered by this job

Top-tier healthcare

Parental leave - 14 weeks

Job summary

Sanofi Waterford, Ireland is seeking a QC Business Process Specialist to drive continuous improvement of laboratory business processes within the QC Lab Team. You will focus on SOP/procedure management, deviation and CAPA handling, GMP compliance, and LIMS/digital systems support to ensure efficient, compliant operations.

The role requires robust regulatory knowledge and strong communication across stakeholders, with opportunities to contribute to cross-functional projects.

Qualifications

• Experience ensuring pharmaceutical regulatory compliance domestically and internationally.
• Experience managing internal audits and regulatory inspections.
• In-depth understanding of FDA, EMA, ICH guidelines.

Responsibilities

• Develop and maintain an effective compliance program.
• Ensure operations meet regulatory requirements and standards.
• Provide training on compliance topics.
• Maintain compliance documentation with accuracy.
• Identify compliance risks and mitigation strategies.
• Support investigations and reporting of incidents.
• Manage CAPA to address incidents and prevent recurrence.

Skills

Compliance management

Regulatory knowledge

CAPA & deviations

Auditing

Documentation skills

LIMS knowledge

Tools

LIMS

Job description

Sanofi Waterford, Ireland is seeking a QC Business Process Specialist to drive continuous improvement of laboratory business processes within the QC Lab Team. You will focus on SOP/procedure management, deviation and CAPA handling, GMP compliance, and LIMS/digital systems support to ensure efficient, compliant operations.

The role requires robust regulatory knowledge and strong communication across stakeholders, with opportunities to contribute to cross-functional projects.