Audit Director, Quality & Compliance
Full-timeSeniorQuality & ComplianceAdvanced Therapies and Cell Therapy ManufacturingCell TherapyBachelors
$80K - $100K/yr
Description
The Audit Director is responsible for leading the strategy, execution, and continuous improvement of the company’s GxP audit program in support of clinical, manufacturing, laboratory, IT/CSV, vendor, and corporate compliance. This role ensures the organization meets global regulatory expectations (FDA, EMA, MHRA, Health Canada, and other authorities). Responsibilities include developing the internal audit program, managing the audit team, executing audits, ensuring inspection readiness, and collaborating cross-functionally to ensure compliance expectations are aligned.
Requirements
Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline. 10+ years of GxP audit experience in biotechnology, pharmaceutical, or cell therapy environment. Strong understanding of FDA, EMA, MHRA regulations. Experience supervising or mentoring employees. Strong analytical, organizational, and communication skills. Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred. Certifications such as ASQ, RQAP-GCP/GMP, RAC, CQA preferred.
Cabaletta Bio
BIOTECHNOLOGY
Chimeric Auto Antibody Receptors
LocationPHILADELPHIA, PA
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