Quality Assurance Supervisor

Revance•Johnson City, TN

23h•Onsite

About The Position

The Quality Assurance Supervisor — Investigations, CAPA, and Change Control executes and oversees site Quality Systems related to deviation investigations, Corrective and Preventive Actions (CAPA), and change control. The role ensures compliance with FDA requirements, ICH guidance, and company quality standards, driving timely, thorough investigations, root cause analysis, sustainable CAPAs, and change control records throughout their lifecycle. The supervisor works closely with Manufacturing, Quality Control, Validation, and Supply Chain to uphold product quality, data integrity, and regulatory readiness. The position reports to the QA Manager and is located at the Johnson City plant. The role also supports audits, Quality Risk Management, site-wide quality initiatives, and continuous improvement. It provides training and mentorship to QA personnel on investigation techniques, documentation standards, and data integrity.

Requirements

Bachelor's degree in Life Sciences, Engineering, or a related technical field.
Minimum 5 years of Quality Assurance experience in a cGMP-regulated pharmaceutical, OTC, or medical device environment.
Demonstrated expertise managing deviation, CAPA, and change control systems.
In-depth knowledge of 21 CFR Parts 210, 211, and 11; ICH Q7–Q10; and relevant USP chapters.
Proficiency in root cause analysis tools and Six Sigma methodologies.
Experience using electronic Quality Management Systems (eQMS), such as MasterControl, Veeva, or ETQ Reliance.
Familiarity with data integrity requirements and ALCOA+ compliance.
Ability to execute inspection-ready investigations, drive timely and effective risk-based corrective actions, manage changes with regulatory and operational impacts in mind, and collaborate across departments.
Ability to track and deliver on commitments with minimal supervision.

Nice To Haves

Experience with FDA inspections and supporting regulatory audits is strongly preferred.

Responsibilities

Manage and execute product and system investigations, including deviations, OOS/OOT results, nonconformances, and complaint-related issues.
Ensure timely investigation initiation, impact assessment, and documentation in accordance with site SOPs and applicable regulations.
Apply structured root cause analysis methods, including 5-Whys, Ishikawa, and Six Sigma tools such as DMAIC, FMEA, and process mapping.
Facilitate cross-functional investigation meetings and maintain inspection-ready documentation.
Drive the creation, approval, and execution of CAPAs; ensure actions are specific, measurable, timely, and effective in addressing root causes.
Monitor CAPA progress, escalate overdue items, support effectiveness checks, and trend and report CAPA data for Quality Metrics and Management Review.
Manage and QA-approve changes affecting procedures, materials, equipment, facilities, test methods, and validated systems.
Evaluate proposed changes for regulatory impact, validation requirements, and risk mitigation using ICH Q9 principles.
Coordinate stakeholders to define, execute, and document change-related tasks before closure; track and trend change control metrics and support audit readiness.
Ensure records are complete, contemporaneous, and compliant with ALCOA+ principles.
Support FDA, customer, and internal audits by presenting investigation files, CAPA evidence, and change control history.
Contribute to Quality Risk Management, FMEAs, and risk evaluations.
Identify and implement improvements to investigation and CAPA lifecycle efficiency and compliance.
Contribute to site-wide quality initiatives, including audit readiness, inspection trend gap closure, and right-first-time performance.
Train and mentor QA personnel on investigation techniques, documentation standards, and data integrity.