Senior Director, Internal Audit & Compliance
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AI Summary
Working Location: Massachusetts, Westborough; Nationwide
Workplace Flexibility: Remote
For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus: https://www.olympusamerica.com/careers.
Job Description
This is a global leadership role responsible for developing, leading, and continuously improving the company’s corporate and internal audit programs across all manufacturing, distribution, R&D, and support sites worldwide. This role ensures ongoing compliance with applicable global regulatory requirements, internal Quality Management System (QMS) standards, and industry best practices within the medical device industry. This role will lead global transformational change for Olympus Corporate Compliance.
This position leads a team of corporate audit professionals responsible for assessing site readiness, identifying compliance risks, driving sustainable corrective and preventive actions (CAPAs), and promoting a culture of quality and continuous improvement. The role serves as a strategic partner to Quality, Regulatory Affairs, Operations, and executive leadership to ensure inspection readiness and compliance excellence across the enterprise.
Job Duties
- Lead and oversee the global corporate audit program across all company sites and critical business functions.
- Own, development, deployment and continuous improvement of the corporate and internal audit quality system process.
- Establish and maintain risk-based corporate and internal audit strategies aligned with applicable global regulations and standards, including FDA, EU MDR/IVDR, ISO 13485, MDSAP, and other regional requirements.
- Direct planning, execution, reporting, and follow-up activities for corporate and internal quality audits.
- Evaluate site compliance to internal QMS requirements, regulatory expectations, corporate procedures, and industry standards.
- Drive enterprise-wide compliance transformation and inspection readiness and ensures sustained compliance across manufacturing, design, clinical, distribution, and post-market activities.
- Partner with site leadership and functional stakeholders to address identified gaps, implement effective CAPAs, and strengthen quality system maturity.
- Monitor and analyse inspection trends, systemic issues, and quality metrics to proactively identify compliance risks and opportunities for improvement.
- Provide strategic guidance and subject matter expertise during regulatory agency inspections and external audits.
- Develop standardized audit methodologies, tools, training programs, and governance processes to ensure consistency and effectiveness globally.
- Build and lead a high-performing global team of internal inspectors and audit professionals, fostering a culture of accountability, collaboration, and continuous improvement.
- Prepare and present corporate audit outcomes, compliance trends, and risk assessments to executive leadership and quality governance forums. Makes recommendations for changes.
- Maintain awareness of evolving global regulatory requirements and industry expectations to ensure ongoing program effectiveness.
Job Qualifications
Required:
- Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field required; advanced degree preferred.
- Minimum of 12 years of progressive experience required in Quality Assurance, Regulatory Compliance, or Quality Systems within the medical device or regulated healthcare industry.
- Significant experience required leading global quality audit or internal inspection programs in a multinational organization.
- Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, EU MDR/IVDR, MDSAP, and other international regulatory frameworks.
- Demonstrated experience interacting with regulatory agencies and supporting external inspections.
- Proven leadership experience managing global teams and influencing senior stakeholders across complex organizations.
- Certified Lead Auditor or equivalent quality certification (ASQ CQA, CQE, or similar).
- Experience supporting remediation programs, compliance transformations, or quality system harmonization initiatives.
- Strong analytical, communication, organizational, and problem-solving skills.
- Familiarity with digital quality systems, audit analytics, and risk management methodologies.
- Ability to travel domestic and internationally as required based on business needs.
Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:
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Competitive salaries, annual bonus and 401(k)* with company match
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Comprehensive medical, dental, vision coverage effective on start date
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24/7 Employee Assistance Program
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Free live and on-demand Wellbeing Programs
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Generous Paid Vacation and Sick Time
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Paid Parental Leave and Adoption Assistance*
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12 Paid Holidays
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On-Site Child Daycare, Café, Fitness Center**
Connected Culture you can embrace:
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Work-life integrated culture that supports an employee centric mindset
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Offers onsite, hybrid and field work environments
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Paid volunteering and charitable donation/match programs
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Employee Resource Groups
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Dedicated Training Resources and Learning & Development Programs
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Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.
The anticipated base pay range for this full-time position is $144,541.00 - $216,812.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
You Belong at Olympus
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Compliance
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