Premier Research Labs · 2 weeks ago
Director of Quality Systems
Austin, TX
Full-time
Onsite
Director/Executive
10+ years expPremier Research Labs is seeking a Director of Quality Systems & Continuous Improvement to lead and mature a robust quality operating system. This role focuses on ensuring products are manufactured and tested in compliance with regulations while driving continuous improvement across operations.
BiotechnologyFitnessHealth CareLife ScienceMedical
Responsibilities
Own and continuously improve PRL’s Quality Management System to ensure day-to-day operational adherence to the quality system requirements of 21 CFR Part 111
Ensure procedures, records, and controls support compliant manufacturing, packaging, labeling, holding, and distribution activities without owning regulatory filings or FDA correspondence
Lead management review of quality system performance, trends, risks, and improvement priorities
Ensure manufacturing processes are supported by approved master manufacturing records (MMRs) and executed using accurate batch production records (BPRs) as required under 21 CFR 111
Partner with Operations to ensure in-process controls are defined, monitored, and effective in preventing deviations and quality failures
Drive improvements that increase right-first-time batch execution and reduce rework or holds
Lead investigation and resolution of deviations, nonconformances, out-of-specification results, and quality events in alignment with 21 CFR 111 requirements for corrective action
Ensure root-cause analysis is thorough, documented, and results in systemic corrective and preventive actions, not superficial fixes
Verify effectiveness of CAPAs and track recurring trends
Ensure supplier qualification, material approval, and incoming material controls meet 21 CFR 111 requirements for identity, purity, strength, and composition
Oversee supplier quality performance, corrective actions, and ongoing improvement initiatives
Collaborate with R&D and Procurement to ensure ingredient specifications and quality agreements are clear and enforceable
Ensure laboratory testing, sampling, and release decisions are executed in accordance with approved procedures and quality standards required under 21 CFR 111
Oversee quality review of batch records, test results, and investigations to support evidence-based product disposition decisions
Drive continuous improvement in turnaround times without compromising quality judgment
Own document control systems to ensure SOPs, specifications, MMRs, and forms are current, controlled, and accessible
Ensure records required under 21 CFR 111 are complete, accurate, legible, and retained appropriately
Maintain strong data integrity and documentation discipline across operations
Conduct internal audits and quality system assessments to verify operational adherence to 21 CFR 111 requirements, independent of external regulatory inspections
Use audit findings to drive system improvements, training, and risk reduction
Prepare the organization to be inspection-ready at all times through execution excellence, not inspection preparation
Establish and monitor quality KPIs tied to 21 CFR 111 execution, CAPA effectiveness, supplier quality, and batch performance
Ensure personnel are trained and qualified for their roles as required under 21 CFR 111, in partnership with Training & Development
Lead cross-functional continuous improvement initiatives that reduce variation, waste, and quality risk
Build and develop a quality team that understands both the spirit and execution requirements of 21 CFR 111
Foster a culture where quality is viewed as a shared responsibility that protects practitioners, patients, and the PRL brand
Qualification
Required
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
Preferred
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
Company
Premier Research Labs
Premier Research Labs is a health & wellness company specializing in non-toxic products.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
J. A. (Jack) Leach
Chief Executive Officer
Nickolas Labinsky
Chief Operations Officer
Company data provided by crunchbase