Regulatory and Compliance Specialist at QPharma Cedar Knolls NJ

Lead a team of five Quality Assurance professionals to drive quality and compliance initiatives across the organization. Own QMS processes ensure regulatory compliance and audit readiness. Foster continuous improvement and manage audit findings. Close quality events while maintaining compliance. Drive performance management and employee development. Partner with HR on staffing and leadership development. Differentiate by scaling quality systems and leveraging expertise.

You own compliance for pharmaceutical operations at Mark Cuban Cost Plus Drug Company, a mission-driven organization expanding access to affordable medicines. You coordinate document control, investigations, and audit readiness across manufacturing, laboratory, and distribution. You work directly with quality assurance, regulatory, and operations teams to maintain FDA cGMP compliance. This role offers the chance to shape a high-impact compliance program from the ground up, with direct influence on patient safety.

Responsible for internal audit system ensuring production and support functions comply with regulations and standards. Conduct internal compliance audits and support company regulatory agency inspections. Provide follow-up on audit action plans and assist management review metrics for the plant.

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