Osani Quality Consulting, LLC.

Osani Quality Consulting, LLC. | Managing Director | 2011 – Present
• Provided cGMP consulting services to pharmaceutical and biopharmaceutical companies, delivering quality, compliance, and efficiency across various projects. 
• Key achievements in contract roles (see details below): 
◦ Authored over 50 procedures (Eli Lilly).
◦ Reduced deviation backlogs by up to 90% (i.e., Novartis and Plastikon Healthcare). 
◦ Authored and implemented over sixty (60) cGMP-compliant QMS procedures (i.e., Akron Biotechnology). 
◦ Completed over 860 deviation investigations, ensuring timely resolution and regulatory adherence (i.e.,    Regeneron). 
◦ Conducted eight (8) CD baseline inspection audits, identifying and mitigating compliance gaps (i.e., McNeil/JnJ). 
◦ Trained staff on GMPs, procedures, and FDA regulations (i.e., Celltrion and ImprimisRx).

Osani Quality Consulting, LLC. - Principle/Owner

Various

Caraco Labs | Associate Director, QA Systems and Compliance | 2011 – 2012
    • Managed all QA department functions, including batch release, document control, stability, investigations,  CAPA, training, and supplier quality. 
Impax Labs | Senior Manager, Regulatory Site Compliance | 2008 – 2011
    • Managed compliance efforts across multiple sites, including audits, Quality Agreements, and regulatory readiness for inspections. 
Poly Peptide Labs | Plant QA Manager | 2007 – 2008
    • Managed all QA functions, including batch release, document control, investigations, CAPA, internal audits, and training.

Other (below)

Life Sciences Quality and Compliance Professional, MSQA, DPS, CQA, CQM (20.9 K connections)

Highly accomplished cGMP professional with 32+ years driving quality and compliance in the pharmaceutical, biopharmaceutical, and API industries. Proven leader in complex projects, ensuring regulatory adherence and continuous improvement through expertise in QMS, risk management, and audits. Proficient in TrackWise and other industry-standard software.

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