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SolomonEdwards · 23 hours ago

Director of Quality

Dallas, TX

Full-time

Onsite

Director/Executive

$140K/yr - $160K/yr

10+ years exp

SolomonEdwards is a growing pharmaceutical company seeking a Director of Quality to ensure compliance with FDA regulations and maintain product safety and quality. The role involves overseeing quality operations, leading audits, and collaborating with various departments to uphold standards.

AccountingConsultingProfessional Services

Growth Opportunities

Hiring Manager

Michael Moore

Responsibilities

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 <797>, <800>, <71>, 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

Qualification

Pharmaceutical quality experienceFDA regulations complianceCGMP for sterile manufacturingAseptic processing knowledgeLeadership experienceRisk assessment skillsDecision-making skillsWritten communicationVerbal communication