Director, IT Solution Owner, QARA

Olympus Corporation of the Americas; Center Valley (Lehigh County); Hybrid; USD 145,000 - 217,000; Full time

Benefits offered by this job

Competitive salaries, annual bonus

401(k) with company match

Employee Assistance Program

Wellbeing programs

Paid Vacation and Sick Time

Parental Leave and Adoption assistance

Holidays

On-site daycare and facilities

Job summary

Olympus Corporation of the Americas is seeking a Director, IT Solution Owner – QA/RA to lead global strategy and end-to-end ownership of digital QA/RA solutions, including eQMS and RIM. You will align with Quality, Regulatory, R&D, Manufacturing, and IT to build multi-year roadmaps and drive value while ensuring compliance and patient safety.

The role requires senior leadership, regulatory knowledge (FDA 21 CFR Part 11/820, ISO 13485, EU MDR/IVDR), and strong collaboration with cross‑functional

Qualifications

• Bachelor’s degree or equivalent experience in related fields.
• Minimum 10 years in the assigned business domain.
• Minimum 7 years in leadership roles with global scope.
• Experience in project/product/platform management and delivery.
• Demonstrated leadership with coaching teams.

Responsibilities

• Own the global QA/RA solution portfolio (eQMS, RIM, complaints, CAPA, audits, document control).
• Define strategy, roadmaps, integrations, and data models for solutions.
• Ensure end‑to‑end traceability, auditability, and regulatory compliance.
• Lead, coach, and develop functional teams across regions and platforms.
• Partner with Product Owners, architects, and delivery teams for successful releases.
• Maintain design integrity, governance, and risk mitigation across deployments.

Skills

Bachelor's degree

Leadership (global scope)

Communication

Business & technical acumen

Project planning

Stakeholder management

Leadership coaching

Regulatory domain knowledge

Agile mindset

Education

Bachelor’s degree in Business, Computer Science, or Engineering

Equivalency/experience

Job description

Working Location:Pennsylvania, Center Valley; Massachusetts, Westborough

Workplace Flexibility:Hybrid

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 ofpatient 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.

The Director, IT Solution Owner – QA/RA is accountable for the global strategy, governance, and end-to-end ownership of digital solutions supporting Quality Assurance and Regulatory Affairs, including eQMS, Regulatory Information Management (RIM), post-market surveillance, and compliance capabilities.

This role ensures QA/RA solutions support regulatory compliance, audit readiness, product quality, and patient safety while integrating with PLM, Manufacturing, and ERP to enable closed-loop quality and the digital thread. The Director partners with Quality, Regulatory, R&D, Manufacturing, and IT leaders to establish multi-year roadmaps, harmonize global processes, and respond to evolving regulatory requirements.

The role is ultimately accountable for solution integrity, validation, compliance, lifecycle performance, and business value across the QA/RA solution domain.

All activities are performed in accordance with Olympus Core Values: agility, empathy, long-term view, unity, and integrity.

Job Duties

• Own the global QA/RA solution portfolio, including eQMS, RIM, complaints, CAPA, audits, document control, and post-market/vigilance solutions.
• Define solution strategy, architecture, roadmaps, integrations, and data models.
• Enable end-to-end traceability and closed-loop quality across PLM, ERP, manufacturing, and post-market systems.
• Ensure solutions support auditability, inspection readiness, security, validation, and regulatory requirements.

Leadership & Delivery

• Lead, coach, and develop functional consultants, developers, analysts, testers, and other solution resources.
• Establish priorities, standards, performance expectations, and development plans.
• Partner with Product Owners, architects, and delivery teams to ensure solutions are designed, built, tested, validated, and deployed successfully.
• Maintain design integrity across releases, regions, and platforms while removing delivery impediments.
• Manage supplier performance, quality, SLAs, and compliance obligations.
• Ensure adherence to enterprise architecture, cybersecurity, data, quality, and compliance standards.
• Govern functional designs, configuration, integrations, and significant solution changes.
• Identify and mitigate solution, operational, and compliance risks.
• Drive simplification, standardization, lifecycle management, and reduction of technical debt.
• Ensure alignment with applicable regulations and standards, including FDA 21 CFR Parts 11/820, ISO 13485, EU MDR, and IVDR.

Stakeholder & Service Management

• Build trusted partnerships with GPOs, Business Process Owners, Product Owners, Business Relationship Managers, and IT leadership.
• Communicate strategy, roadmap, delivery status, risks, decisions, and value realization.
• Ensure alignment across dependent business processes and technology platforms.
• Partner with IT service continuity and disaster recovery teams to maintain and test continuity plans for critical solutions.
• Use operational data, incidents, user feedback, automation, and emerging technologies to improve performance, adoption, and efficiency.
• Champion an AI-first mindset, identifying opportunities to apply AI, intelligent automation, and analytics to simplify processes, improve productivity and decision‑making, and deliver measurable value.
• Ensure AI capabilities used within regulated processes are appropriately governed for security, privacy, data integrity, validation, quality, and regulatory compliance.

Job Qualifications

Required:

• Bachelor’s degree in Business, Computer Science, Engineering or equivalent experience.
• Minimum of 10 years’ experience in the assigned business domain.
• Minimum of 7 years’ experience in leadership roles with Global Scope.
• Deep knowledge of the assigned Business Domain/area and corresponding processes (KPIs, best practices, trends).
• Work experience in the IT environment with a broad understanding of a wide variety of applications and technical capabilities, and how those varied solutions can support the organization’s strategic goals.
• Experience in project/product/platform management.
• Proven experience in product-, platform-, or project‑delivery environments.
• Demonstrated leadership experience (Minimum of 5 years), including coaching and mentoring teams.
• Experience collaborating with Product Owners, Program Managers, Analysts, Engineers, and QA resources.
• Strong business and technical acumen.
• Excellent communication and facilitation skills.
• Detail‑oriented, structured, and decisive.

Preferred:

• Agile certification preferred but not mandatory.

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:

Competitive salaries, annual bonus and 401(k)* with company match

24/7 Employee Assistance Program

Free live and on-demand Wellbeing Programs

Generous Paid Vacation and Sick Time

Paid Parental Leave and Adoption Assistance*

12 Paid Holidays

On‑Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

Work‑life integrated culture that supports an employee centric mindset

Offers onsite, hybrid and field work environments

Paid volunteering and charitable donation/match programs

Employee Resource Groups

Dedicated Training Resources and Learning & Development Programs

The anticipated base pay range for this full‑time position in this location is$144,541.00-$216,812.00/ year, plus potential for annual bonus(subject toplan eligibility andother requirements).

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 [e-mail]. 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.