Astrix · 2 hours ago
Quality Associate Director
Garland, TX
Full-time
Onsite
Lead/Staff, Director/Executive
$110K/yr - $130K/yr
8+ years expAstrix is a fast-growing, mission-driven contract manufacturer specializing in high-performance skin and hair care products. They are seeking an experienced Quality Director to lead its Quality function, focusing on building scalable systems and serving as the primary quality authority for FDA and client-facing audits.
ConsultingInformation Technology
Hiring Manager
Emily Streb
Responsibilities
Lead, mentor, and develop Quality Assurance and Quality Control teams
Design, implement, and scale quality systems aligned with cGMP, FDA 21 CFR Parts 210/211, ISO 22716, and related standards
Serve as the primary point of contact for FDA, regulatory, and client-facing audits
Own validation strategy and execution (equipment, process, cleaning)
Drive investigation of nonconformances, root cause analysis, CAPAs, and quality metrics trending
Partner cross-functionally to embed quality throughout new product development, tech transfers, and scale-ups
Oversee sampling, testing, and product release activities
Lead the Quality organization through growth and change while maintaining audit readiness
Qualification
Required
8–10 years of progressive quality management experience in contract manufacturing, beauty/personal care, or OTC-regulated environments
Minimum 3 years in a leadership role
Proven experience managing FDA and client-facing audits
Strong validation expertise
Bachelor's degree in a scientific or engineering discipline
Deep knowledge of FDA 21 CFR 210/211, OTC regulations, cosmetic standards, and ISO 22716
Strong communication, documentation, and cross-functional leadership skills
Preferred
Advanced degree or ASQ certifications
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
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