QC Compliance & Process Specialist, Microbiology Lab

Sanofi Inc.; Sheffield; On-site; GBP 51,000 - 73,000; Full time

Benefits offered by this job

Top-tier healthcare

14 weeks gender-neutral parental leave

Job summary

Sanofi is seeking a QC Business Process Specialist to strengthen the QC Lab Team in Waterford. You will drive continuous improvement, standardization, and GMP-compliant processes across SOP/procedure management, deviation and CAPA handling, and LIMS/digital systems support.

You will work with cross-functional teams to ensure efficient, compliant operations that meet regulatory requirements (FDA/EMA/ICH). Strong communication, project management, and document control skills are essential as you

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 (e.g., FDA, EMA, ICH).

Responsibilities

• Contributing to the development and maintenance of an effective compliance program.
• Ensuring all operations comply with relevant regulatory requirements and other international standards.
• Providing training and guidance to employees on compliance-related topics.
• Maintaining compliance-related documentation, ensuring accuracy and completeness.
• Identifying potential compliance risks and contributing to the development of strategies to mitigate them.
• Supporting the investigation and reporting of compliance incidents.
• Managing CAPA to address compliance incidents and preventing recurrence.

Skills

Strong communication skills

Job description

Sanofi is seeking a QC Business Process Specialist to strengthen the QC Lab Team in Waterford. You will drive continuous improvement, standardization, and GMP-compliant processes across SOP/procedure management, deviation and CAPA handling, and LIMS/digital systems support.

You will work with cross-functional teams to ensure efficient, compliant operations that meet regulatory requirements (FDA/EMA/ICH). Strong communication, project management, and document control skills are essential as you