Job Description

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.

Lead the Quality Operations of the FDA regulated sterile drug manufacturing facility and oversee daily

quality operations, ensuring accurate and efficient quality control processes.

Ensure ongoing compliance with Wholesale Drug Distribution requirements.

Act as Management Representative during regulatory inspections and external audits, including FDA,

state boards of pharmacy, and third parties.

Maintain compliance with FDA regulations, cGMP, and other relevant quality standards.

Provide subject matter expertise for parenteral drug manufacturing in an aseptic environment at the

503b Outsourcing Facility.

Oversee batch record review, release, and disposition for compounded sterile products (CSPs).

Ensure procedures and documentation support cGMP manufacturing, sterile compounding, and aseptic

processing.

Manage the deviation/CAPA program, change control, complaints, OOS/OOT investigations, and

product recalls.

Lead the internal audit programs and ensure timely closure of findings.

Review and approve validation protocols, qualification reports, SOPs, and regulatory submissions.

REQUIRED QUALIFICATIONS

Bachelors degree in engineering, Life Sciences, or a related discipline.

Minimum 10+ years of experience in the aseptic processing of sterile drugs for human use

Minimum 5+ years of experience in a leadership capacity.

In-depth knowledge of:

21 CFR Parts 210/211.

Section 503B and related FDA guidance.

cGMP for sterile drug manufacturing using aseptic processing.

USP <797> , <800> , <71> Sterility Tests, and relevant state regulations.

Proven experience managing quality systems in sterile compounding or manufacturing environments.

Demonstrated success during FDA inspections and external audits.

Strong decision-making, risk assessment, and communication skills.

PREFERRED EXPERIENCE:

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., MasterControl, TrackWise).

Six Sigma, ASQ CQE/CQA, or other quality certifications.

KEY COMPETENCIES:

Expert knowledge of quality systems in cGMP environments.

Expert knowledge of aseptic manufacturing of parenteral drugs.

Strategic thinking with hands-on execution capability.

Leadership and team-building skills.

Regulatory inspection experience and confidence under scrutiny.

Proactive risk management and decision-making.

Job Tags

Similar Jobs