Director of Quality

Our growing pharmaceutical client is seeking a Director of Quality to join their Dallas, TX location.

$/yr – $/yr

• Oversee all Quality Operations and Compliance functions, ensuring efficient and compliant daily operations
• Act as the site Quality leader, defining strategy, setting standards, and driving continuous improvement
• Lead batch record review, release, and disposition of compounded sterile products (CSPs)
• Ensure adherence to FDA, cGMP, USP , , , and state regulatory requirements
• Manage deviation/CAPA, change control, complaint, and recall processes
• Act as the primary site representative during FDA and state board inspections and external audits
• Lead internal audits and oversee timely closure of findings
• Review and approve validation protocols, qualification reports, SOPs, and regulatory submissions
• Collaborate with manufacturing, engineering, and operations to maintain quality across all departments

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Engineering, or related field
• 10+ years of pharmaceutical quality experience, including 5+ years in a leadership capacity
• Deep understanding of 21 CFR Parts 210/211 and Section 503B regulations, cGMP for sterile manufacturing and aseptic processing, USP , , and related state pharmacy standards
• Proven success managing quality systems in sterile compounding or manufacturing environments
• Demonstrated experience with FDA inspections and regulatory audits
• Strong leadership, risk assessment, and decision‑making skills
• Excellent written and verbal communication abilities

Direct hire, Full‑time, On Site Daily

Director

Pharmaceutical Manufacturing

Solomon Edwards Group , LLC is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, or protected veteran status.

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