Director of Quality Systems

Premier Research LabsAustin, TX
10dOnsite

About The Position

Premier Research Labs is seeking a Director of Quality Systems & Continuous Improvement to lead and mature a robust, practitioner-grade quality operating system that ensures products are consistently manufactured, tested, and released in accordance with 21 CFR Part 111 requirements, while driving continuous improvement across operations. This role does not own regulatory affairs or external FDA interactions. Instead, it ensures that all operational quality systems, controls, and records required under 21 CFR 111 are effectively designed, implemented, followed, and improved—so regulatory readiness is a natural outcome of disciplined execution, not reactive effort. This position is ideal for a quality leader with deep dietary supplement industry experience who believes quality is a strategic advantage, not a compliance obligation.

Requirements

  • 10+ years of progressive quality leadership experience within the dietary supplement or nutraceutical manufacturing industry.
  • Demonstrated hands-on experience implementing and maintaining operational quality systems aligned with 21 CFR Part 111.
  • Strong understanding of batch records, specifications, supplier qualification, investigations, and product release systems.
  • Proven ability to lead cross-functional teams in a fast-growing manufacturing environment.
  • Bachelor’s degree in Science, Engineering, Quality, or related field.

Nice To Haves

  • Experience supporting practitioner-focused or premium supplement brands.
  • Lean / Six Sigma or continuous-improvement certification.
  • Experience scaling quality systems during rapid growth or facility expansion.

Responsibilities

  • Quality Management System (QMS) & 21 CFR 111 Execution
  • Production, Process & In-Process Control Oversight
  • CAPA, Deviations & Investigations
  • Supplier Quality & Raw Material Controls
  • Laboratory, Testing & Product Release Systems
  • Document Control & Record Integrity
  • Internal Audits & Quality System Effectiveness
  • Quality Metrics, Training & Continuous Improvement
  • People Leadership & Quality Culture
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