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.

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.

• 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.

• Educational Background: Bachelor’s degree in Engineering, Life Sciences, or a related discipline. M.S., Pharm.
  
  D., or MBA. Preferred.
• Aseptic
  
  Experience:
  
  Minimum 8+ years of experience in the aseptic processing of sterile drugs for human use.
• Leadership: Minimum 5+ years in a leadership capacity.
• Subject Matter Expertise:
  Expert-level, hands‑on knowledge of:

• Section 503B and all related FDA guidance documents.
• USP and USP standards, including USP 71 Sterility Tests.
• Relevant State Board of Pharmacy regulations pertaining to outsourcing facilities.
• 21 CFR Parts 210/211 and cGMP for sterile drug manufacturing.

• Inspection Success: Demonstrated success and confidence leading FDA inspections and external audits.

• Advanced degrees (M.S., Pharm.
  
  D., or MBA) desirable.
• Experience with parenteral drug manufacturing, aseptic filling lines, or cleanroom operations.
• Familiarity with automation, ERP/QMS systems (e.g., Master Control, Track Wise).
• Six Sigma, ASQ CQE/CQA, or other quality certifications.

• Regulatory SME: Deep, authoritative knowledge of quality systems in 503B and cGMP environments.
• Technical Mastery: Expert knowledge of aseptic manufacturing of parenteral drugs.
• Execution: Strategic thinking paired with the ability to execute "hands‑on" in a fast‑paced environment.
• Risk Management: Proactive approach to risk management and regulatory scrutiny.