QC Process & Compliance Specialist

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

Job summary

Sanofi Waterford seeks a QC Business Process Specialist to drive compliance and continuous improvement across lab operations, focusing on SOP management, CAPA handling, deviation management, and GMP alignment.

You will collaborate with QC Microbiology, support LIMS and digital systems, ensure regulatory readiness, and maintain robust documentation to sustain audit readiness and product quality.

Qualifications

• Experience ensuring compliance with pharma regulations (FDA/EMA/ICH).
• Experience with internal audits and regulatory inspections.
• Knowledge of GMP, CAPA, deviation management.
• Familiarity with SOP/procedure management and document control.

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

GMP/audit experience

Deviation handling

SOP management

Education

Bachelor's degree in life sciences

Tools

LIMS

Document control systems

Job description

Sanofi Waterford seeks a QC Business Process Specialist to drive compliance and continuous improvement across lab operations, focusing on SOP management, CAPA handling, deviation management, and GMP alignment.

You will collaborate with QC Microbiology, support LIMS and digital systems, ensure regulatory readiness, and maintain robust documentation to sustain audit readiness and product quality.