Overview:
Our client is seeking an experienced Quality Director to guide and grow the Quality organization! This senior leadership role calls for a quality professional with deep experience in beauty, personal care, or OTC manufacturing and a strong track record of leading FDA and customer audits.

Type: Direct Hire
Location: Dallas County, TX
Rate: $100K - $130K

Responsibilities:

• Provide leadership, coaching, and development to Quality Assurance and Quality Control teams, fostering accountability and continuous improvement.
• Establish, implement, and continuously improve scalable quality systems in alignment with cGMP, FDA 21 CFR Parts 210/211, ISO 22716, and other relevant regulations and standards.
• Lead audit preparedness efforts and act as the main liaison for FDA, regulatory agencies, and customer audits, ensuring effective follow-up on observations and corrective actions.
• Oversee validation activities (equipment, process, cleaning, etc.) and ensure nonconformances, investigations, root cause analyses, and quality trends are properly documented and reported.
• Partner cross-functionally with R&D, Operations, and Project Management to embed quality throughout product development, technology transfers, and scale-up activities.
• Review and interpret quality data, delivering practical guidance and feedback to manufacturing teams.
• Direct sampling programs and analysis to confirm products consistently meet defined quality requirements.
• Guide the organization through periods of growth and change by implementing the right balance of structure, flexibility, and accountability.
• Develop, standardize, and maintain GMP-compliant SOPs, records, and internal workflows to support compliance and audit readiness.
• Monitor, analyze, and communicate key quality metrics to promote visibility and continuous improvement.
• Stay informed on regulatory updates, industry trends, evolving standards, market dynamics, and potential risks or improvement opportunities impacting the business.

Qualifications:

• 8 - 10 years of progressive quality experience in contract manufacturing, beauty/personal care, or OTC-regulated environments, including 3+ years in a leadership capacity.
• Demonstrated experience leading FDA, customer, and third-party audits, with direct involvement in FDA interactions and remediation efforts.
• Bachelor’s degree in a scientific or engineering field required; advanced degree or professional certifications (ASQ CQE, CQA, CMQ/OE) preferred.
• Strong working knowledge of FDA 21 CFR 210/211, OTC monographs, cosmetic regulations, and quality systems such as ISO 22716 and ISO 9001.
• Proven ability to lead teams through organizational growth, implement new quality systems, and improve overall performance.
• Excellent written and verbal communication skills, with the ability to clearly convey complex quality concepts to diverse audiences.
• Highly organized and detail-oriented, with the ability to manage multiple initiatives and competing priorities.
• Advanced capability in SOP authoring, documentation control, root cause analysis, and corrective action management.
• Comfortable working with ERP systems, QMS platforms, document control tools, and standard productivity software.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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