Teams at QuVa Pharma, Inc.

Supervise QC Microbiology laboratory operations, mentor staff, and ensure cGMP compliance. Oversee sterility, endotoxin, and environmental testing, review/approve data, investigate OOS results, manage SOPs and LMS documentation, coordinate with contract labs, and lead continuous improvement to maintain product quality and regulatory compliance.

Manage and coordinate DEA compliance across multiple manufacturing sites: inventories, ARCOS reporting, CSOS and DEA 222 processing, controlled substance movement, training, registrations, audits, quota submissions, and regulatory updates to ensure pharmaceutical regulatory adherence and security.

Lead cross-functional teams to design and implement process improvements, airflow visualization programs, validations, and tech transfers for sterile drug manufacturing. Perform feasibility and scale-up studies, root-cause investigations, CAPA, process characterization, and technical writing. Support regulatory readiness, contamination control, and production performance to improve yield, reduce deviations, and ensure compliance with GMP/ICH/QbD expectations.