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
● Bachelor’s 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.
...Overview: This role serves as the site SME for all cleaning validation and verification activities related to intermediate and API... ...cleaning validation, environmental monitoring, and/or purified water systems, preferably in a pharmaceutical or biotech manufacturing...
...Job Title: Cloud Engineer Job Summary The Cloud Engineer is responsible for designing... ...across platforms such as AWS, Azure, or Google Cloud. The position supports both project... ...certifications such as AWS Solutions Architect, AWS SysOps, Azure Administrator, Azure Solutions...
...Property Group is a high-performing, growth-driven real estate team built on strong systems, accountability, and results. Our Inside Sales Agents play a critical role in the success of the business by owning the front end of the sales pipeline. This position is...
Join a global community of talented professionals to shape the future of AI. Earn up to $15 USD/hr and additional rewards based on quality of submission. Outlier is committed to improving the intelligence & safety of AI models. Owned and operated by Scale AI , weve ...
...Community healthcare facility looking to bring on Nurse Manager PACU! Sign on Bonus and Relocation!! The PACU RN Manager in collaboration with the Perioperative Director creates a common vision to facilitate continuous quality improvement in the delivery of patient...