Head of Quality Control

Department: Quality Assurance / Quality Control

Reports To: CEO / Executive Assistant

Location: On-site — Phoenix, Arizona Manufacturing Facility

Employment Type: Full-time

Industry Focus: Private-label OTC drugs, personal care, and nutraceuticals (dietary supplements)

Position Summary

The Head of Quality Assurance is the senior quality leader responsible for the design, implementation, and continuous improvement of Specialty Formulations & Manufacturing’s Quality Management System (QMS) across all private-label product categories: over-the-counter (OTC) drugs, personal care and cosmetic products, and nutraceuticals / dietary supplements. This role owns regulatory readiness (FDA, state boards of pharmacy or health, and applicable international standards), batch release integrity, customer and brand-owner quality expectations, supplier quality, laboratory oversight, complaint and deviation systems, and inspection / audit performance.

The Head of QA is both a hands-on quality professional and a people leader. In a private-label environment, the position must balance speed-to-market and custom formulations with uncompromising compliance, documentation discipline, and brand-protection for client companies.

Primary Responsibilities

• Own, maintain, and continually improve the site Quality Management System covering OTC drug CGMP (21 CFR 210/211), dietary supplement CGMP (21 CFR 111), and cosmetic / personal care good manufacturing practices (including 21 CFR 700 series and MoCRA-related requirements as applicable).
• Establish quality policy, quality objectives, management review cadence, and quality metrics (batch right-first-time, deviation rate, complaint rate, CAPA effectiveness, on-time release, audit findings).
• Author, approve, and control SOPs, specifications, master batch records, testing protocols, validation protocols, and quality agreements.
• Serve as primary quality contact for FDA inspections (drug, dietary supplement, and cosmetic), state inspections, customer audits, certification bodies, and third-party laboratories.
• Maintain inspection readiness at all times: documentation control, training files, equipment logs, environmental monitoring, stability programs, and reserve samples.
• Own FDA correspondence related to quality (483 responses, warning letter remediation, facility registration / listing support, product listing support as assigned).
• Final authority for batch disposition (release, reject, or quarantine) of OTC, personal care, and nutraceutical lots.
• Oversee in-process controls, finished-product testing, incoming raw material and component qualification, and certificate of analysis review.
• Ensure appropriate specifications exist for each private-label SKU, including customer-specific requirements captured in quality agreements and product technical files.
• Oversee environmental monitoring, water systems, cleaning validation / verification, equipment qualification (IQ/OQ/PQ), and process validation appropriate to product risk. Deviations, Complaints, CAPA & Change Control
• Own deviation, OOS / OOT, nonconformance, customer complaint, and product quality complaint systems, including investigation quality and timely close-out.
• Lead CAPA from root-cause analysis through effectiveness checks.
• Administer change control for formulas, processes, equipment, suppliers, specifications, and labels that can affect product quality.
• Manage product hold, recall / market withdrawal readiness, and mock recall exercises. Supplier, Customer & Brand-Owner Quality
• Qualify and periodically requalify raw material, component, packaging, and contract laboratory suppliers; maintain approved supplier lists and quality agreements.
• Build a culture in which quality is owned on the floor—not only in the QA office—through training,
• Ensure cGMP, hygiene, documentation, and data-integrity training is current for all relevant employees and contractors.

Required Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Chemical Engineering, or a closely related scientific field. Advanced degree preferred.
• 2+ years of progressive quality experience in regulated manufacturing, with at least 5 years in a leadership role.
• Direct experience with at least two of the three product categories: OTC drugs (21 CFR 210/211), dietary supplements (21 CFR 111), and personal care / cosmetics. Experience across all three is strongly preferred.
• Demonstrated ownership of FDA inspection readiness and successful inspection outcomes.
• Proven ability to write and defend investigations, CAPAs, and regulatory responses.
• Working knowledge of USP, NSF or equivalent supplement standards, ISO 22716 (cosmetics GMP) or equivalent, and stability / shelf-life principles.
• Strong command of documentation systems, batch record review, and electronic or hybrid record control.

Preferred Qualifications

• Familiarity with MoCRA, facility registration, product listing, and adverse event reporting for cosmetics.
• Familiarity with OTC monograph reform (CARES Act) and OTC labeling / Drug Facts requirements.
• Experience with dietary supplement identity testing, adulteration risk (e.g., spiked ingredients), and structure/function claim boundaries.

Core Competencies

• Intellectual honesty and backbone — willing to stop a batch or a shipment when the science or the record does not support release.
• Clear writing — SOPs, investigations, and FDA/customer responses that are precise, factual, and defensible.
• Operational partnership — works with production, purchasing, R&D / formulation, and sales without becoming a bottleneck or a rubber stamp.
• Risk-based thinking — applies controls commensurate with product risk (drug vs. cosmetic vs. supplement) rather than a one-size-fits-all bureaucracy.
• Teaching ability — raises the quality literacy of operators, formulators, and customer-facing staff.
• Confidentiality and professionalism with brand-owner formulas, claims, and audit findings.

Working Conditions

This is a hands-on, on-site role in a manufacturing environment. The Head of QA will spend time on the production floor, in the laboratory, in the warehouse, and in the quality office. The position requires the ability to review documents for extended periods, walk the facility, and respond to quality events, including during inspections. Some evening or weekend availability may be required during FDA inspections, customer audits, or critical batch investigations.

Authority

This position has independent authority to reject raw materials, halt production, withhold batch release, initiate product holds, and escalate quality risk directly to ownership. Quality decisions are not subordinate to

production schedule or sales commitments.

This job description outlines the general nature and essential functions of the role. It is not an exhaustive list of all duties, responsibilities, or qualifications. Duties may be added, removed, or modified to meet business and regulatory needs.

Pay: $31.25 - $40.87 per hour

Expected hours: 40.0 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Education:

• Bachelor's (Preferred)

Work Location: In person