Executive Director, QA Microbiology
Core
Develop and execute strategy for the GMP Microbiology program to ensure high-quality, safe, and effective products compliant with global regulatory expectations.
Role type
Executive Director, Quality Assurance Microbiology
Builds
GMP Microbiology program and quality management capabilities
Domain
Biopharmaceuticals / Quality Assurance / Microbiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiological expectations in drug development, CMC and GMP regulations, FDA and Europe submission experience (IND, BLA, CBE, PAS), Quality risk identification and mitigation, Resource allocation, Strategic planning, Stakeholder management
Preferred skills
Building quality culture, Operating in ambiguous environments, Articulating quality concepts across networks
Technologies
GMP, CMC, FDA, Europe regulatory frameworks
Responsibilities
Implement value-added microbiology programs based on sound science, Monitor program performance using metrics, Embed quality tools and risk management processes, Address complex technical and global regulatory standards, Partner with QA Operations to ensure compliant aseptic practices, Represent the organization with regulatory agencies and corporate partners, Translate business strategies into executable action plans, Allocate resources based on program priorities
Seniority
Executive Director, 18+ years experience
