Seeking a mission-driven professional, the full-time Senior Director, QC Program Implementation will establish and lead Sabin's first dedicated QC capability, designing a cGMP-compliant QC framework while collaborating with internal teams and external partners in a fully remote environment.
Key Responsibilities:
Establish and maintain governance and oversight of laboratories and CDMOs performing testing on behalf of Sabin
Provide sponsor-level QC oversight of analytical readiness, ensuring compliance with regulatory requirements and quality standards
Develop and evolve Sabin's outsourced QC capability, including performance metrics and continuous improvement initiatives
Required Qualifications:
Bachelor's degree in a relevant scientific discipline; advanced degree preferred
14+ years of experience in pharmaceutical/biopharmaceutical QC or related GMP environments
Experience with analytical PPQ readiness and regulatory submissions for vaccine or biologics development
Strong knowledge of GMP QC principles and analytical method lifecycle management
Proven ability to manage technical relationships with external partners in a virtual or matrixed organization