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 culture across drug development and manufacturing
Domain
Biopharmaceuticals / Microbiology / Quality Assurance
Required skills
Microbiology program strategy, CMC regulatory submissions (IND, BLA, CBE, PAS), GMP compliance, risk management, aseptic practice oversight, resource allocation, stakeholder liaison
Preferred skills
Building quality culture, operating in ambiguous environments, translating business strategy to execution
Technologies
GMP, CMC, FDA, EMA regulations
Responsibilities
Implement value-added microbiology programs based on sound science and regulatory requirements; Monitor program performance using metrics and drive continuous improvement; Embed quality tools and risk management processes; Address complex technical and global regulatory standards; Partner with QA Operations to ensure compliant aseptic practices; Lead microbiology decision-making to protect patient safety; Represent the organization with regulatory agencies and stakeholders; Translate business strategies into executable action plans; Allocate resources based on program priorities; Establish high standards for performance management.
Seniority
Executive Director, 18+ years experience