Associate Director/Director Program Management, QC Testing

Role: Associate Director/Director Program Management, QC Testing at TG Therapeutics, overseeing outsourced analytical testing activities for biologics, cell/gene therapies, supporting clinical and commercial programs. Responsibilities: serve as primary liaison with CDMOs and testing labs, manage supplier relationships, develop and track project timelines, ensure compliance with GMP, GLP, ICH, FDA, EMA regulations, oversee budgets, and coordinate cross-functional testing activities. Qualifications: 12+ years in biotech/pharma, 3+ years managing external testing vendors, with expertise in QC testing for biologics, cell/gene therapies, and supporting clinical/regulatory phases. Technical skills include GMP/GLP knowledge, and familiarity with analytical techniques such as HPLC, mass spectrometry, PCR/qPCR, flow cytometry, and microbial testing. Preferred certifications: PMP, CQE, CQA, Lean Six Sigma; education: Bachelor’s in Life Sciences, advanced degree preferred. HighValue: biologics, cell/gene therapy, regulatory compliance, GMP/GLP, clinical and commercial support. Work setup: not specified, but workload implies interaction with global vendors and internal teams.