GMP Quality & Compliance Leader

Eacademy Sanofi; Framingham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Sanofi in Framingham, MA is seeking a Head of Quality Compliance to oversee GMP activities and compliance programs across site operations including Framingham Biologics, Biosurgery, and Northborough. The role leads a team to ensure readiness for inspections and drives continuous improvement while maintaining a robust quality management system.

The candidate will oversee relationships with regulators and stakeholders, drive KPIs, and manage risks.

Qualifications

• Bachelor’s degree in a science or equivalent with 10+ years of experience in a cGMP regulated industry.
• Experience hosting regulatory inspections (PAI, General GMP, For-Cause inspections, etc.).
• Proven track record in leading cross-functional teams and driving compliance.
• Strong communication and collaboration across functions and levels.

Responsibilities

• Developing, implementing, and maintaining an effective compliance program.
• Ensuring that the Site complies with all laws, regulations, and standards applicable in the pharmaceutical industry.
• Establishing and maintaining relationships with regulators, industry associations, customers, suppliers, and other stakeholders, and representing the company in compliance-related matters.
• Maintaining a system to ensure compliance and quality risks are properly identified, tracked and mitigated.
• Ensuring the company is always prepared for inspections by regulatory bodies for topics related to dossier compliance.
• Ensure that any compliance issues are reported to the relevant authorities in a timely manner.
• Manage and resolve any compliance issues, or allegations that arise and take appropriate corrective and preventive actions.
• Establishing and monitoring KPIs and metrics for the site compliance, and reporting on the results to management.
• Host the Business Owners self-inspection and other key systems
• Identify and drive continuous improvement initiatives and projects to enhance the site compliance fostering a culture of compliance
• Leading and managing the compliance team, including hiring, training, coaching, professional development and performance evaluation.

Skills

Regulatory inspections experience

Effective communication

Cross-functional collaboration

Project management

Problem solving

GMP knowledge

Leadership

Education

Bachelor’s or Master’s degree in science

Job description

Sanofi in Framingham, MA is seeking a Head of Quality Compliance to oversee GMP activities and compliance programs across site operations including Framingham Biologics, Biosurgery, and Northborough. The role leads a team to ensure readiness for inspections and drives continuous improvement while maintaining a robust quality management system.

The candidate will oversee relationships with regulators and stakeholders, drive KPIs, and manage risks.