Director of Quality Systems

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.

• 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.