On-site (with flexibility for up to 50% remote work)
Quality systems compliance
External manufacturing oversight
Gmp and regulatory standards
Bristol Myers Squibb is seeking a Senior Manager for Quality Compliance in External Manufacturing, responsible for overseeing compliance and quality systems within the pharmaceutical and biologics sectors. The role emphasizes leadership, project management, and collaboration with external manufacturing partners to ensure adherence to regulatory standards
Job Summary
Provides quality compliance oversight for pharma and biologics CMOs within External Manufacturing, driving effective implementation and continuous improvement of Quality Systems.
Leads continuous improvement and compliance projects, serves as Local Process Owner for Quality Systems, and acts as Lead Site Change Champion for manufacturing launches and technical transfers.
Represents ExM on global quality teams, provides quality/compliance subject matter expertise, and serves as the subject matter expert in audits/inspections.
Matching Summary
Match Score: 85
Bristol Myers Squibb is seeking a Senior Manager for Quality Compliance in External Manufacturing, responsible for overseeing compliance and quality systems within the pharmaceutical and biologics sectors. The role emphasizes leadership, project management, and collaboration with external manufacturing partners to ensure adherence to regulatory standards.
Skills & Requirements
Must-have
Quality Systems compliance
External Manufacturing oversight
GMP and regulatory standards
Health Authority interactions
CMO technical transfer projects
Nice-to-have
high-performance team culture
cross-functional relationships
pro-active continuous improvement
Key Requirements
8-10+ years pharmaceutical industry experience
BSc or equivalent in scientific discipline
Extensive technical knowledge of chemical, biological, or pharmaceutical operations
In-depth knowledge of cGMP and GDP regulations
Direct experience with external manufacturers
Ability to build relationships and influence decisions