Jobs at Padagis LLC

The Associate Director develops and executes pricing strategies, analyzing market dynamics, leading pricing initiatives, and ensuring compliance in the pharmaceutical industry.

Lead a team of five QA professionals to oversee site quality and compliance activities including audits, deviations, validation, data review, change control, investigations, CAPA, and continuous improvement. Manage internal and external (FDA) audit responses, deliver training, provide performance feedback, and support HR matters to maintain cGMP compliance.

Administer and improve the LMS, manage course content and SOPs, generate compliance reports, and provide user support. Coordinate training logistics, develop basic eLearning, and maintain accurate training records. Provide HR and leadership administrative support, assist employee engagement and events, and partner with Talent and department leaders to enhance learning and operational effectiveness.

Lead capital projects in a GMP pharmaceutical manufacturing site from concept through commissioning, validation, and operational handoff. Define scope, schedule, budget, manage vendors/contractors, drive risk mitigation, oversee equipment installation and startup, ensure FDA/GMP compliance and ALCOA+ data integrity, lead IQ/OQ/PQ validation, align cross-functional stakeholders, mentor junior staff, and drive continuous improvement.

Lead cross-functional continuous improvement projects across pharmaceutical manufacturing lines using SPC, DOE, FMEA, lean and Six Sigma methods. Develop SOPs and MBRs, mentor junior engineers, integrate automation, track KPIs, drive cost-saving initiatives, ensure GMP/FDA compliance, and provide production troubleshooting and documentation.

Perform microbiological testing and environmental monitoring (water, air, equipment) using USP <60>, <61>, <62>, and <51>, analyze and document results, support method validation, act as SME, and participate in continuous improvement to ensure pharmaceutical product quality.