Director, Internal Audit

Hologic • Marlborough, MA

100d • $154,200 - $274,100

About The Position

We are 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.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Medical, or related field.
• Lead Auditor certification and qualifications for relevant regulations.
• ISO 13485:2016 training and other regulatory training.
• Minimum of 10 years of experience in Quality Systems and GMP within medical devices, pharmaceuticals, or a comparable regulated environment.
• Proven track record of successfully completing internal and external audits within FDA-regulated cGMP facilities.

Nice To Haves

• Extensive knowledge of internal auditing principles, methodologies, and best practices.
• Familiarity with global regulatory agency trends and notified body requirements.
• Proficiency in training internal auditors and maintaining their qualifications through relevant programs.

Responsibilities

• Define, implement, and monitor a robust Internal Audit Program.
• Ensure compliance with FDA regulations, ISO standards, and other global regulatory requirements.
• Plan, implement, and monitor comprehensive Internal Audit Programs.
• Conduct gap assessments and audit planning to identify compliance risks.
• Report audit findings and collaborate with cross-functional teams and senior management.
• Manage audit teams and develop staff to create a culture of quality and compliance.

Benefits

• Comprehensive training upon joining and continued development throughout your career.
• Bonus eligibility based on performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees