Director/Associate Director of Quality Control (QC)

We’re partnering with a leading cellular therapy organization that is seeking a highly motivated Director or Associate Director of Quality Control (QC) with expertise in ddPCR, flow cytometry, and cell-based assay methods. This role offers an exciting opportunity to lead quality initiatives supporting cellular therapies within a GMP environment.

Key Responsibilities:

• Conduct GMP In-Process Control (IPC), lot release, and stability testing using ddPCR, flow cytometry, and cell-based methods.
• Lead method optimization, transfer, qualification, and validation for clinical drug product testing.
• Prepare detailed and organized reports and presentations describing analytical results.
• Facilitate cross-functional training and continuous improvement within the QC team.
• Develop and maintain Quality Control (QC) and Quality Management System (QMS) standards to align with internal and global regulatory requirements.
• Oversee stability studies, raw materials qualification, and analytical development strategies to ensure product quality.
• Manage method transfers and outsourced testing activities with CMOs.
• Write, review, and approve protocols, validation reports, and regulatory submissions.

Qualifications:

• Bachelor’s degree in Biology or related field; advanced degree preferred.
• 8+ years of QC laboratory experience within biotechnology, clinical, or pharmaceutical environments, ideally under GMP, GLP, or CLIA regulations.
• In-depth knowledge of FDA, ISO, EMA, GMP, and ICH standards applicable to biologics and cell therapies.
• Hands-on experience with multicolor flow cytometry, ddPCR, ELISA, cell-based assays, and cell culture techniques.
• Proven ability to lead high-performing QC teams, manage complex projects, and collaborate effectively with stakeholders.
• Experience with regulatory submissions, particularly those leading to commercial product approval.
• Excellent communication, organizational, and problem-solving skills.

This full-time position is based in San Diego, CA, and offers an opportunity to make a significant impact in the cellular therapy field.