Audit Program Lead: Regulatory & Customer Audits

Promega Corporation; Madison (WI); On-site; USD 120,000 - 160,000; Full time

Job summary

Promega Corporation is seeking an Audit Program Lead to own our audit program, covering internal audits, customer audits, and regulatory inspections. You will lead with QARA experts to plan, execute, and host audits, scaling to full ownership of the program.

AI-supported tools help track schedules, findings, and actions, while you maintain primary technical authority over audit judgments and strategy, ensuring compliance across all audit types.

Qualifications

• Bachelor's degree in life sciences with 5+ years of relevant industry experience.
• Alternatively, associate's degree with 10+ years of relevant industry experience.
• 5–10 years of experience in Quality Control/Quality Assurance.
• 5–10 years of experience performing compliance audits in ISO, FDA, or internationally regulated (EU) environments.
• Excellent knowledge of domestic and international regulations for medical device diagnostics.
• Excellent interpersonal, leadership, and coaching skills.
• Strong written and oral communication skills with formal presentation experience.
• Comfortable using AI-supported tools for tracking audit schedules and findings.

Responsibilities

• Builds and gains approval for the internal audit schedule and conducts internal audits with compliant records.
• Leads external audit facilitation—scheduling, executing, and hosting customer and regulatory inspections—including mock audits.
• Collaborates with quality leadership to present the audit program to customers and regulators; supports supplier-facing audits.
• Tracks audit findings and action plans through to closure; uses trends to improve the quality system.
• Trains new internal auditors and orients staff on external audit processes.
• Keeps audit activity current in the eQMS and coordinates urgent audit needs.

Skills

Quality Assurance

Leadership

Coaching

Auditing

Communication

Time Management

AI tools awareness

Regulatory knowledge

Education

Bachelor's degree in life sciences

Associate's degree

Tools

eQMS

AI-assisted auditing tools

Job description

Promega Corporation is seeking an Audit Program Lead to own our audit program, covering internal audits, customer audits, and regulatory inspections. You will lead with QARA experts to plan, execute, and host audits, scaling to full ownership of the program.

AI-supported tools help track schedules, findings, and actions, while you maintain primary technical authority over audit judgments and strategy, ensuring compliance across all audit types.