Senior Quality Assurance Manager

Senior Quality Assurance Manager

The Senior Quality Assurance (QA) Manager is responsible for consulting on quality assurance operations and ensuring compliance with FDA regulations and industry standards. This role aids in the development, implementation, and continuous improvement of quality systems to support product safety and regulatory readiness. Responsibilities include : completing required actions for quality management system improvement, reviewing and writing standard operating procedures (SOPs), assisting with the creation and implementation of training programs to ensure compliance, coordinating activities to ensure alignment with leadership, providing additional support as needed, and mentoring teams on best practices in quality assurance and regulatory compliance.

Essential skills include regulatory remediation expertise, the ability to work independently and on-site in East Troy, WI, understanding of the homeopathic and nutraceuticals industry in an FDA-regulated environment, a proven track record of leading quality initiatives and regulatory remediation projects, strategic guidance on regulatory compliance, inspection readiness, and enforcement response, and quality assurance expertise.

Additional skills and qualifications include a minimum of 10 years of experience in quality and compliance roles within FDA-regulated industries and a bachelor's degree in Engineering or a scientific field.

This role requires comfort with traveling to the site in East Troy, WI. The candidate will collaborate with junior team members and must be a subject matter expert in this field, as in-house expertise is limited.

This is a contract position based out of East Troy, WI. The pay range for this position is $60.00 - $70.00 / hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following : medical, dental & vision, critical illness, accident, and hospital, 401(k) retirement plan pre-tax and Roth post-tax contributions available, life insurance (voluntary life & AD&D for the employee and dependents), short and long-term disability, health spending account (HSA), transportation benefits, employee assistance program, and time off / leave (PTO, vacation or sick leave).

This is a hybrid position in East Troy, WI. The application deadline for this position is anticipated to close on Dec 1, 2025.