Associate Director, Manufacturing QA in San Diego, California at Abzena Inc.

Implement and maintain “QA on the floor” practices to support GMP manufacturing.

Lead QA Operations team in reviewing batch records, manufacturing documentation, and ensuring timely batch disposition.

Provide QA oversight for Drug Substance and Drug Product manufacturing processes.

Support review and approval of Master Batch Records and associated documentation.

Collaborate with internal stakeholders and clients to address quality-related issues, including deviations and audit findings.

Participate in client audits and regulatory inspections as needed.

Ensure compliance with applicable regulations (US, EU, ROW), cGMP, 21 CFR, USP, and internal quality standards.

Maintain effective communication with project managers and manufacturing teams to align on timelines and deliverables.

Drive continuous improvement initiatives within QA Operations.

Train, mentor, and develop QA staff to ensure high performance and engagement.

Collaborate directly with clients to resolve issues (e.g., client comments on executed batch records, root cause investigation for major or critical deviation) and participate in client audits.

Provide support to manager and SLT as needed.

Bachelor's degree in science or engineering with a minimum of 5 years of relevant experience including leading and developing teams.

Relevant experience as a quality leader.

Knowledge of industry standards and regulation requirements for biologics and parenteral substances in clinical development and commercial.

Knowledge of GMP regulations (US, EU and ROW), good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards, and guidance.