Audit Program Lead: Internal & Regulatory Excellence

Promega Corporation; Madison (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

Promega Corporation is seeking an Audit Program Lead to own the established audit program, overseeing internal audits, customer audits, and regulatory inspections. You will partner with QARA experts and quality leadership to plan, execute, and host audits, driving continuous improvement across audit types and preparing for future ownership of the program.

As the primary technical authority, you will guide audit scheduling, findings, and action plans, with AI-supported tools to track progress.

Qualifications

• Bachelor’s in life sciences or equivalent with relevant industry experience.
• 5–10 years in Quality Control/Quality Assurance.
• 5–10 years auditing ISO/FDA/international regs.
• Strong knowledge of domestic and international medical device regulations.
• Excellent interpersonal, leadership, coaching skills.
• Ability to prioritize multiple tasks under deadlines.
• Strong written and oral communication; formal presentation experience.
• Comfort with AI-assisted tools for audits and documentation.

Responsibilities

• Build and approve internal audit schedule and conduct audits.
• Lead external audits with customers and regulators; conduct mock audits.
• Collaborate with quality leadership to present audit program during external audits.
• Track findings and action plans to closure; use data to flag system gaps.
• Train new internal auditors and orient staff to external processes.
• Maintain audit activity in eQMS and coordinate urgent audit needs.

Skills

Leadership

Coaching

Communication

Presentation

Time management

Education

Bachelor's degree in life sciences

Associate's degree with 10 years experience

Tools

AI-assisted audit tools

Job description

Promega Corporation is seeking an Audit Program Lead to own the established audit program, overseeing internal audits, customer audits, and regulatory inspections. You will partner with QARA experts and quality leadership to plan, execute, and host audits, driving continuous improvement across audit types and preparing for future ownership of the program.

As the primary technical authority, you will guide audit scheduling, findings, and action plans, with AI-supported tools to track progress.