QC Compliance & Process Specialist

Sanofi Inc.; Swindon; On-site; GBP 41,000 - 56,000; Full time

Benefits offered by this job

Health insurance

Job summary

Sanofi is seeking a QC Business Process Specialist to drive compliance, SOP management, CAPA handling, and GMP alignment within the QC Lab. You will support digital systems and LIMS processes to ensure regulatory requirements are met and operations run efficiently.

The role emphasizes training, documentation accuracy, and rapid response to compliance incidents and deviations, enabling safe and reliable microbiology workflows.

Qualifications

• Experience ensuring compliance with pharmaceutical regulations and standards.
• Experience managing internal audits and regulatory inspections, including follow-up.
• Understanding of FDA/EMA/ICH guidelines and GMP expectations.

Responsibilities

• Develop and maintain an effective compliance program.
• Ensure operations comply with regulatory requirements and international standards.
• Provide training on compliance topics to employees.
• Maintain accurate compliance documentation.
• Identify risks and help mitigate them; support investigations and CAPA.

Skills

Compliance

CAPA handling

GMP knowledge

SOP management

Regulatory inspections

Tools

LIMS

QMS

Job description

Sanofi is seeking a QC Business Process Specialist to drive compliance, SOP management, CAPA handling, and GMP alignment within the QC Lab. You will support digital systems and LIMS processes to ensure regulatory requirements are met and operations run efficiently.

The role emphasizes training, documentation accuracy, and rapid response to compliance incidents and deviations, enabling safe and reliable microbiology workflows.