QC Compliance & Process Excellence Specialist

Sanofi; Munster; On-site; EUR 60,000 - 90,000; Full time

Job summary

Sanofi Waterford, Ireland, is seeking a QC Business Process Specialist to enhance the QC Microbiology workflow by driving regulatory-compliant processes, SOP management, and CAPA handling. This role focuses on GMP-aligned procedures and LIMS/digital systems support to ensure efficient, compliant lab operations.

The position emphasizes SOP/procedure governance, deviation handling, and continuous improvement within a global biopharma environment, offering opportunities to contribute to a robust

Qualifications

• Experience in ensuring compliance with pharmaceutical regulations and standards.
• Experience in managing internal audits and external regulatory inspections.
• Strong communication skills to convey compliance requirements to stakeholders.

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 strategies to mitigate them
• Supporting the investigation and reporting of compliance incidents
• Managing CAPA to address compliance incidents and prevent recurrence

Skills

Regulatory compliance

Audit experience

Stakeholder communication

Analytical thinking

Tools

LIMS

Job description

Sanofi Waterford, Ireland, is seeking a QC Business Process Specialist to enhance the QC Microbiology workflow by driving regulatory-compliant processes, SOP management, and CAPA handling. This role focuses on GMP-aligned procedures and LIMS/digital systems support to ensure efficient, compliant lab operations.

The position emphasizes SOP/procedure governance, deviation handling, and continuous improvement within a global biopharma environment, offering opportunities to contribute to a robust