Quality Business Owner (PQR)

Role Summary

Quality Business Owner within the Quality Systems Team, based in Framingham, MA. You will own process, system, and data, and lead site-wide process evolutions. You will support audits and inspections, present processes to auditors, and identify remediation actions from findings under the guidance of the global process owner. You will help ensure QMS health at Mass BioCampus facilities and coordinate training and communications on inspection outcomes.

Responsibilities

• Conduct routine data quality checks and validations to identify and address any process, system or data issue.
• Develop and deliver training programs, principles and best practices.
• Identify and assess risks and implement mitigation strategies.
• Lead on-site continuous improvement initiatives in line with global processes and practices.
• Oversee the computerized systems to ensure they meet all requirements.
• Establish and monitor key performance indicators in line with global guidance.
• Represent the site in the CoP and, if requested, participate in the CoE while ensuring local communication.
• Represent Sanofi Global Quality when interacting with health authorities for global processes.
• Oversee overall QMS health at the Mass BioCampus facilities to ensure quality and compliance.
• Compile data for and ensure compliance with procedures that govern Quarterly Management Reviews, Product Quality Reviews, Site Quality Council, Site Risk Profile, and investigation system maintenance for site needs.

Qualifications

• Required: 5+ years of experience in quality or manufacturing within the pharmaceutical/biotech industry.
• Required: Ability to analyze complex data sets and identify patterns, discrepancies, and areas for improvement (using Power BI and Excel).
• Required: Experience reviewing and reporting KPIs.
• Required: Strong focus on continuous improvement with the ability to implement plans successfully.
• Required: Strong verbal and written communication skills with the ability to work collaboratively with others.
• Preferred: Experience with change controls and complaints.
• Preferred: Experience working with global partners.
• Preferred: Experience with deviations and CAPA management.

Education

• Bachelor’s degree in science or a relevant field.