Director, Internal Audit

Director, Internal Audit

Are you a seasoned quality and compliance professional with a passion for driving excellence in regulated environments? We're looking for a Director, Internal Audit to join our team and play a pivotal role in ensuring the effectiveness of our global Quality Systems. In this critical leadership position, you will define, implement, and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If you thrive in a fast-paced, collaborative environment and have a proven track record of fostering a culture of quality, this is your opportunity to make a lasting impact on patient safety and innovation.

Knowledge

• Deep understanding of FDA Code of Federal Regulations (21 CFR 820), ISO standards (e.g., ISO 13485 : 2016, ISO 14971), MDSAP, and other global regulatory requirements.
• Expertise in Quality Systems and GMP compliance in regulated industries such as medical devices or pharmaceuticals.
• Extensive knowledge of internal auditing principles, methodologies, and best practices.
• Familiarity with global regulatory agency trends, notified body requirements, and systemic improvement processes.
• Proficient in gap assessments, audit planning, and identifying compliance risks.

Skills

Behaviors

Experience

Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required, and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $154,200- $274,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs, and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.