Quality Compliance & Process Lead — QC Microbiology

Sanofi Inc.; York and North Yorkshire; On-site; GBP 51,000 - 77,000; Full time

Benefits offered by this job

Top-tier healthcare

Parental leave

Health benefits

Job summary

Sanofi Inc. is seeking a QC Business Process Specialist to support the QC Microbiology team in Waterford, Ireland.

You will drive continuous improvement, standardization, and compliance of laboratory business processes, focusing on SOP management, deviation and CAPA handling, GMP compliance, and LIMS/digital systems support. The role emphasizes ensuring regulatory alignment, maintaining documentation, providing training, and mitigating compliance risks across global standards.

Qualifications

• Experience in ensuring compliance with local, national, and international pharmaceutical regulations and standards.
• Experience in 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

Regulatory compliance

Audit management

CAPA handling

Documentation accuracy

Job description

Sanofi Inc. is seeking a QC Business Process Specialist to support the QC Microbiology team in Waterford, Ireland.

You will drive continuous improvement, standardization, and compliance of laboratory business processes, focusing on SOP management, deviation and CAPA handling, GMP compliance, and LIMS/digital systems support. The role emphasizes ensuring regulatory alignment, maintaining documentation, providing training, and mitigating compliance risks across global standards.