Job Details

Overview

Position: Director, Quality Control - Biologics

We are seeking an experienced and driven Director of Quality Control to lead QC operations at a fast-growing biologics CDMO site in San Diego. The successful candidate will oversee all Quality Control activities, including analytical testing, microbiology, stability, and raw material programs, ensuring the highest standards of GMP compliance and scientific excellence. As a key member of the site leadership team, this individual will be responsible for building, mentoring, and empowering a high-performing QC organization that supports both clinical and commercial manufacturing programs.

Responsibilities

• Provide strategic and operational leadership for the QC department, overseeing testing of drug substance and drug product in compliance with global GMP requirements.
• Lead and develop teams across Analytical, Microbiology, and Raw Material functions, fostering a culture of accountability, technical excellence, and continuous improvement.
• Ensure robust method transfer, qualification, and validation activities in alignment with regulatory expectations and project timelines.
• Oversee data integrity, documentation, and laboratory compliance systems, ensuring inspection readiness at all times.
• Partner cross-functionally with QA, Manufacturing, Process Development, and Technical Services to support investigations, CAPAs, and product lifecycle management.
• Establish, monitor, and report on QC performance metrics and drive efficiency improvements across the department.
• Act as the QC lead during client audits and regulatory inspections, supporting site compliance and client satisfaction.
• Champion a strong Quality culture, reinforcing company values of integrity, collaboration, and scientific rigor.

Qualifications / Skills Required

• Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or related field required; advanced degree preferred.
• Minimum of 10 years' experience in Quality Control or Analytical Development within biologics, bioconjugates, or related GMP environments.
• Proven track record leading QC teams in a CDMO or biopharmaceutical manufacturing setting.
• Comprehensive knowledge of US and EU GMP regulations, ICH guidelines, and industry standards for biologics testing.
• Demonstrated success in method validation, analytical troubleshooting, and regulatory inspection readiness.
• Strong leadership, communication, and organizational skills with the ability to manage multiple priorities in a dynamic environment.
• High attention to detail, ethical integrity, and commitment to quality excellence.

Why Join?

This is a unique opportunity to take ownership of a QC function at a site positioned for significant growth. You'll work with diverse biologic and bioconjugate programs that make a global impact—within a collaborative and empowering culture where quality is at the heart of everything we do.

Employment type

• Full-time

Job function

• Quality Assurance, Science, and Research

Industries

• Pharmaceutical Manufacturing, Biotechnology Research, and related fields