Job Description

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 Director of Quality, located in Dallas, TX. The Director of Quality provides strategic and operational leadership for the Quality function at a 503B outsourcing facility, ensuring full compliance with FDA regulations, cGMP, and applicable USP and state pharmacy standards. This role oversees all Quality Assurance (QA), regulatory compliance, and sterile manufacturing oversight, ensuring that compounded drug products are safe, effective, and consistently manufactured.

DUTIES & RESPONSIBILITES:

• Lead the Quality Operations and Compliance functions at the 503B Outsourcing Facility and oversee daily quality operations, ensuring accurate and efficient quality control processes.
• Serve as the site Quality leader, responsible for setting the strategic vision and ensuring that all quality activities align with regulatory requirements and corporate objectives.
• Maintain compliance with FDA regulations, cGMP, and other relevant quality standards.
• Collaborate closely with the operations management team to ensure effective communication and
• coordination between departments.
• Act as Management Representative during regulatory inspections and external audits, including FDA,
• state boards of pharmacy, and third parties.
• 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 internal audit programs and ensure timely closure of findings.
• Review and approve validation protocols, qualification reports, SOPs, and regulatory submissions.

REQUIRED QUALIFICATIONS

• Bachelor’s degree in Pharmacy, Chemistry, Engineering, Life Sciences, or a related discipline.
• Minimum 10+ years of experience in pharmaceutical quality roles, with at least 5 years in a leadership capacity.
• Strong leadership and team management skills
• In-depth knowledge of:

-21 CFR Parts 210/211,

-Section 503B and related FDA guidance,

-cGMP for sterile drug manufacturing,

-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 and Risk Assessment skills.
• Excellent communication and Organizational skills
• Ability to work on-site in Dallas, TX (Monday - Friday)

PREFERRED EXPERIENCE:

• Advanced degree (M.S., Pharm.D., or MBA) desirable.
• Experience in the Pharmaceutical or Healthcare Industry is 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 503B and GMP environments
• Strategic thinking with hands-on execution capability
• Leadership and team-building skills
• Regulatory inspection experience and confidence under scrutiny
• Excellent written and verbal communication
• Proactive risk management and decision-making

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