QC Process & Compliance Specialist

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

Job summary

Sanofi is seeking a QC Business Process Specialist to strengthen the QC Microbiology governance by guiding SOPs, deviation handling, and CAPA processes in a GMP-compliant setting. The role emphasizes standardization of laboratory business processes and alignment with regulatory requirements, including LIMS and digital systems support.

Ideal candidates will have deep experience with pharmaceutical regulations (FDA/EMA/ICH), and a proven ability to drive continuous improvement, maintain compliance

Qualifications

• Experience ensuring compliance with local, national, and international pharmaceutical regulations and standards.
• Experience managing internal audits and external regulatory inspections, including preparation, execution, and follow-up.
• In-depth understanding of pharmaceutical regulations, guidelines, and standards (FDA, EMA, ICH).

Responsibilities

• Contributing to the development and maintenance of an effective compliance program.
• Ensuring operations comply with regulatory requirements and international standards.
• Providing training and guidance to employees on compliance-related topics.
• Maintaining compliance-related documentation for accuracy and completeness.
• Identifying potential compliance risks and helping develop mitigation strategies.
• Supporting investigation and reporting of compliance incidents.
• Managing CAPA to address incidents and prevent recurrence.

Skills

Regulatory compliance

Audits & inspections

CAPA management

Documentation

Tools

LIMS

Job description

Sanofi is seeking a QC Business Process Specialist to strengthen the QC Microbiology governance by guiding SOPs, deviation handling, and CAPA processes in a GMP-compliant setting. The role emphasizes standardization of laboratory business processes and alignment with regulatory requirements, including LIMS and digital systems support.

Ideal candidates will have deep experience with pharmaceutical regulations (FDA/EMA/ICH), and a proven ability to drive continuous improvement, maintain compliance