From Promega's posting. “We” and “our” refer to the employer.
OUR TEAM:
Promega is hiring an Audit Program Lead to own our audit program, and we are looking for an experienced auditor ready to step into program leadership. The program is established and covers internal audits, customer audits, and regulatory inspections. You will lead it, drawing on subject matter experts from across QARA to plan, execute, and host audits.
You will apply what we learn across audit types to strengthen how we schedule, execute, and prepare, and you will work directly with quality leadership, with coaching and exposure to customer and regulatory audit strategy as you grow into full ownership of the program. If you have a solid audit background and are ready to lead at the next level, this is a role where you can build breadth and credibility.
YOUR ROLE:
As Audit Program Lead, you'll lead Promega's established audit program — internal audits, customer audits, and regulatory inspections — drawing on subject matter experts from across QARA to plan, execute, and host audits. You'll own the internal audit schedule and the records that demonstrate compliance and take on customer and regulatory body inspections working directly with quality leadership.
You'll apply what you learn across audit types to strengthen how Promega schedules, executes, and prepares for audits, with coaching and exposure to customer and regulatory audit strategy as you grow into full ownership of that side of the program.
AI-supported tools can help track audit schedules, organize findings, and flag overdue actions. They cannot walk into a mock audit and know when an answer sounds rehearsed rather than true, or decide whether a finding is a paperwork gap or a real process failure. That judgment, on both the internal and external side of the program, is yours — you are the primary technical authority here, not a check on what a tool produced.
JOB OBJECTIVE:
The Audit Program Lead leads Promega's established internal and external audit program — building and executing the internal audit schedule, partnering with QARA subject matter experts and quality leadership to plan, execute, and host customer and regulatory audits, and tracking findings and action plans through to closure — growing into full ownership of customer and regulatory audit strategy over time.
CORE DUTIES:
1. Builds and gains approval for the internal audit schedule, plans and conducts (or ensures completion of) internal audits, and maintains records that demonstrate compliance.
2. Leads external audit facilitation — scheduling, executing, and hosting customer and regulatory body inspections in partnership with subject matter experts across QARA — and runs mock audits to close out improvement areas ahead of them.
3. Works directly with quality leadership to present the audit program to customers and regulators during external audits, building toward full ownership of that presence as your audit-strategy experience grows, and steps in on the occasions supplier-facing audit support is needed.
4. Tracks audit findings and action plans through to closure, and uses trending data across internal and external audits to flag where the quality system needs attention before it becomes a finding.
5. Trains new internal auditors and orients staff on the external audit process.
6. Keeps audit activity current in the eQMS, and partners with quality leadership on urgent or time-sensitive audit needs.
KEY QUALIFICATIONS:
1. 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.
2. 5 to 10 years of experience in Quality Control/Quality Assurance.
3. 5 to 10 years of experience performing compliance audits in an ISO, FDA, or internationally regulated (EU) environment.
4. Excellent working knowledge of domestic and international regulations applicable to the design, development, manufacturing, and marketing of medical device diagnostic reagents.
5. Excellent interpersonal, leadership, and coaching skills.
6. Demonstrated ability to prioritize and coordinate multiple tasks under deadlines.
7. Strong written and oral communication skills, including formal presentation experience.
8. 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.
PREFERRED QUALIFICATIONS:
1. 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.
2. Working knowledge of ICH Q7 and other API (Active Pharmaceutical Ingredient) regulatory requirements.
PHYSICAL DEMANDS: 1. Ability to occasionally move objects weighing up to 30 lbs.
At Promega, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.
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