GMP Compliance & Quality Process Specialist

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

Benefits offered by this job

Health benefits

14 weeks parental leave

Job summary

Sanofi is seeking a QC Business Process Specialist to support the QC Microbiology team. You will drive continuous improvement, standardization, and GMP-compliant management of laboratory processes, SOPs, deviations, CAPAs, and LIMS/digital systems within the QC Lab.

You will help ensure regulatory alignment, robust documentation, and training across the organization, contributing to a compliant, efficient laboratory operation at our Waterford site.

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

Communication

Attention to detail

Analytical thinking

Project management

Job description

Sanofi is seeking a QC Business Process Specialist to support the QC Microbiology team. You will drive continuous improvement, standardization, and GMP-compliant management of laboratory processes, SOPs, deviations, CAPAs, and LIMS/digital systems within the QC Lab.

You will help ensure regulatory alignment, robust documentation, and training across the organization, contributing to a compliant, efficient laboratory operation at our Waterford site.