Audit Program Lead

Promega•Madison, WI

About The Position

Promega is seeking an experienced Audit Program Lead to manage its established audit program, which encompasses internal audits, customer audits, and regulatory inspections. This role involves leading the program by leveraging subject matter experts from across QARA to plan, execute, and host audits. The Audit Program Lead will be responsible for applying learnings across different audit types to enhance scheduling, execution, and preparation processes. This position offers direct collaboration with quality leadership, with opportunities for coaching and exposure to customer and regulatory audit strategies as the role evolves into full program ownership. It is an ideal opportunity for an auditor with a strong background looking to advance into program leadership, build breadth, and gain credibility.

Requirements

Bachelor's degree in the life sciences plus 5 years of relevant industry experience, OR associate's degree plus 10 years of relevant industry experience.
5 to 10 years of experience in Quality Control/Quality Assurance.
5 to 10 years of experience performing compliance audits in an ISO, FDA, or internationally regulated (EU) environment.
Excellent working knowledge of domestic and international regulations applicable to the design, development, manufacturing, and marketing of medical device diagnostic reagents.
Excellent interpersonal, leadership, and coaching skills.
Demonstrated ability to prioritize and coordinate multiple tasks under deadlines.
Strong written and oral communication skills, including formal presentation experience.
Comfortable using AI-supported tools for tracking audit schedules, organizing findings, and drafting routine documentation, and verifies what those tools produce rather than taking it at face value.

Nice To Haves

Formal auditor training and certification, e.g. an Exemplar Global-certified ISO 13485 Lead Auditor or Internal Auditor course, or equivalent ASQ Certified Quality Auditor (CQA) credential.
Working knowledge of ICH Q7 and other API (Active Pharmaceutical Ingredient) regulatory requirements.

Responsibilities

Builds and gains approval for the internal audit schedule.
Plans and conducts (or ensures completion of) internal audits.
Maintains records that demonstrate compliance.
Leads external audit facilitation, including scheduling, executing, and hosting customer and regulatory body inspections in partnership with subject matter experts across QARA.
Runs mock audits to identify and address improvement areas before external audits.
Works directly with quality leadership to present the audit program to customers and regulators during external audits.
Steps in on occasions when supplier-facing audit support is needed.
Tracks audit findings and action plans through to closure.
Uses trending data across internal and external audits to identify areas where the quality system needs attention before issues arise.
Trains new internal auditors.
Orients staff on the external audit process.
Keeps audit activity current in the eQMS.
Partners with quality leadership on urgent or time-sensitive audit needs.