Quality Director

Company Description

Mark Cuban Cost Plus Drug Company, PBC is transforming the pharmaceutical industry by offering medications at fixed, transparent profit margins, making affordable options accessible for patients affected by market and regulatory challenges. We are committed to addressing and eliminating unnecessary drug shortages in the United States. Our mission is to improve access to life-saving medicines for everyone, without compromise.

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. This role serves as the primary Subject Matter Expert (SME) for all regulatory and compliance matters involving 503B Outsourcing Facilities, USP , and USP . You will oversee sterile drug manufacturing using aseptic processing, wholesale drug distribution, and comprehensive compliance activities.

Qualifications

• Regulatory Technical Authority: Serve as the definitive SME for parenteral drug manufacturing in an aseptic environment at the 503B Outsourcing Facility.
• Compliance Leadership: Ensure all quality activities and facility designs align strictly with FDA 503B

guidance, USP (Sterile Preparations), and USP (Hazardous Drugs).

• Audit Representation: Act as the Lead Management Representative and technical SME during regulatory inspections and external audits, including the FDA, state boards of pharmacy, and third parties.
• Operational Oversight: Lead Quality Operations for the FDA-regulated sterile drug manufacturing facility, ensuring accurate and efficient quality control processes.
• Documentation & Review: Oversee batch record review, release, and disposition for compounded sterile products (CSPs) while ensuring procedures support cGMP and aseptic processing standards.
• Quality System Management: Manage the deviation/CAPA program, change control, complaints, OOS/OOT investigations, and product recalls.
• Validation & SOPs: Review and approve validation protocols, qualification reports, and SOPs with a specific lens on 503B and USP compliance.
• Distribution Compliance: Maintain ongoing compliance with Wholesale Drug Distribution requirements.