Quality Director

COMPANY MISSION :

Mark Cuban Cost Plus Drug Company, PBC is committed to providing affordable medicines at fixed, transparent profit margins to help patients left behind by market and regulatory forces. We aim to end unnecessary drug shortages in the United States by making and selling medications that everyone can access and afford.

ROLE DESCRIPTION :

This is a full-time on-site role for a Quality Director, located in Dallas, TX.

The Quality Director provides strategic and operational leadership for the Quality Unit at the Mark Cuban Cost Plus Drug Company. Areas of Quality oversight include but are not limited to : Sterile drug manufacturing using aseptic processing, Wholesale Drug Distribution and Compliance activities.

RESPONSIBILITIES :

• ? Serve as a company Quality leader, responsible for setting the strategic vision and ensuring that all

quality activities align with FDA and State requirements and corporate objectives.

quality operations, ensuring accurate and efficient quality control processes.

state boards of pharmacy, and third parties.

503b Outsourcing Facility.

processing.

product recalls.

REQUIRED QUALIFICATIONS

21 CFR Parts 210 / 211.

Section 503B and related FDA guidance.

cGMP for sterile drug manufacturing using aseptic processing.

USP

Sterility Tests, and relevant state regulations.

PREFERRED EXPERIENCE :

KEY COMPETENCIES :