Director, Internal Audit

Director, Internal Audit

Marlborough, MA, United States

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

• Proven ability to successfully plan, implement, and monitor comprehensive Internal Audit Programs.

• Strong analytical and strategic thinking skills to assess compliance risks and leverage data for proactive improvements.

• Excellent verbal and written communication skills for reporting audit findings and collaborating with cross-functional teams and senior management.

• Leadership skills to manage audit teams, develop staff, and create a culture of quality and compliance.

• Effective time management and organizational abilities to handle multiple tasks, ensure timely corrective actions, and meet audit deadlines.

• Proficiency in training internal auditors and maintaining their qualifications through relevant programs.

Behaviors

• Detail-oriented and highly organized, ensuring thorough audits and precise documentation.

• Proactive and adaptable to changes in global regulatory environments, anticipating trends and adjusting audit plans accordingly.

• Ethical and professional, fostering trust and accountability in all audit-related activities.

• Collaborative, working effectively across functions and locations to achieve company-wide compliance goals.

• Motivational and supportive, promoting a positive and engaged workplace culture that prioritizes quality and compliance.

Experience

• Required: 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.

• Demonstrated experience in building and promoting a culture of quality that drives employee engagement and exceptional customer experiences.

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.

Agency and Third-Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

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

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