Director of Quality Control

2 months ago

San Diego, United States Meet Full time

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.

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