Audit-Ready Quality Systems & Compliance Lead

Bristol-Myers Squibb; Leiden; On-site; EUR 70,000 - 100,000; Full time

Job summary

Bristol Myers Squibb in Leiden is seeking a Senior Specialist, Quality Systems and Compliance who will own and oversee Quality Systems per local and global standards at the site level. The role involves coordinating pre-inspection activities, preparing for audits, and maintaining inspection readiness across functions.

You will work with cross-functional teams, analyze process performance, drive continuous improvement, and support Health Authority inspections for multiple markets.

Qualifications

• Bachelor's degree preferred; alternative is HS diploma or Associate with relevant experience.
• 4+ years in a regulated industry; 1+ year in quality system experience.
• Experience with FDA/EMA regulations in biopharma or cell therapy is preferred.
• Proficient with electronic systems and databases.

Responsibilities

• Support the administration and maintenance of the Quality Systems, including metrics reporting and analysis, stakeholder communication, and governance meeting facilitation.
• Supports, maintains and specializes in QMS systems and processes as applicable , such as Risk Management, E-Logbooks, Document and Records Management, Annual Product Quality Review and Quality Council.
• Coordinate pre-inspection activities, including streamlining information needed from other groups at the site, and above-site (Global) level.
• Support the site to prepare and execute corporate audits and Health Authority inspections for multiple markets.
• Share data/ knowledge within and across site and network and participate in community of practices.
• Build & maintain strong relationships with partner functions.

Skills

Quality systems knowledge

Regulatory understanding

Data interpretation

Verbal and written communication

Cross-functional collaboration

Education

Bachelor's degree preferred

High school diploma / Associate degree

Tools

MS Office

Electronic systems

Databases

Job description

Bristol Myers Squibb in Leiden is seeking a Senior Specialist, Quality Systems and Compliance who will own and oversee Quality Systems per local and global standards at the site level. The role involves coordinating pre-inspection activities, preparing for audits, and maintaining inspection readiness across functions.

You will work with cross-functional teams, analyze process performance, drive continuous improvement, and support Health Authority inspections for multiple markets.