Astrix · 11 hours ago
Quality Director
Dallas County, TX
Full-time
Onsite
Director/Executive
$100K/yr - $130K/yr
8+ years expAstrix is seeking an experienced Quality Director to guide and grow their Quality organization. This senior leadership role involves providing leadership to Quality Assurance and Quality Control teams while ensuring compliance with industry regulations and continuous improvement in quality systems.
ConsultingInformation Technology
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
Qualification
Required
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
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
Preferred
advanced degree or professional certifications (ASQ CQE, CQA, CMQ/OE)
Company
Astrix
Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.
1001-5000 employees
H1B Sponsorship
Astrix has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (9)
2023 (10)
2022 (16)
2021 (11)
Funding
Current Stage
Late StageLeadership Team
Dale Curtis
Chief Executive Officer
Reid E. Simpson
Chief Financial Officer
Recent News
Company data provided by crunchbase