Principal Quality Consultant

We are seeking a dedicated Principal Quality Consultant to join our team and provide expert guidance on quality assurance and regulatory compliance. In this role, you will conduct thorough reviews of 483 and warning letters, assess current processes, and execute gap assessments and root cause analyses. Your expertise will be essential in developing and implementing CAPA plans, including corrective actions and preventive measures, and ensuring their successful execution.

Responsibilities

• Review 483 and warning letters and evaluate current processes and procedures.
• Complete gap assessments and conduct root cause analysis.
• Develop CAPA plans with immediate corrective actions, long-term preventive measures, designated responsible owners, completion timelines, and metrics for effectiveness.
• Create comprehensive reports with action plans and recommendations for discussion with stakeholders.
• Mentor teams on best practices in quality assurance and regulatory compliance.
• Provide strategic guidance on regulatory compliance, inspection readiness, and enforcement response.

• Expertise in quality assurance with the ability to work independently.
• Capability to travel to a facility in East Troy, WI.
• Minimum of 15 years of experience in quality and compliance roles within FDA-regulated industries.
• Bachelor's degree in Engineering or a Scientific field.
• Proven track record of leading quality initiatives and regulatory remediation projects.

• Previous experience in the homeopathic industry is preferred, but transferrable skills from any FDA-regulated environment are required.

The work environment is located in East Troy, WI, on farmland, requiring comfort with a rural setting rather than a pristine manufacturing facility. This role is ideal for consultants who enjoy short-term projects at a competitive rate. You will work with junior team members and must bring subject matter expertise, as in-house knowledge is limited.

Job Type & Location

This is a Contract position based out of East Troy, WI.

Pay and Benefits

The pay range for this position is $125.00 - $150.00/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
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in East Troy,WI.

Application Deadline

This position is anticipated to close on Nov 15, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $125 - $150