Director, IT Solution Owner, QARA

Olympus Corporation of the Americas; Center Valley (Lehigh County); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive salaries

Annual bonus

401(k) with company match

Comprehensive medical coverage

Employee Assistance Program (EAP)

Paid vacation & sick time

Parental leave & adoption assistance

12 paid holidays

On-site daycare, café, fitness center

Job summary

Olympus Corporation of the Americas is seeking a Director, IT Solution Owner – QA/RA to lead the global strategy and end-to-end ownership of digital solutions for Quality Assurance and Regulatory Affairs, including eQMS, RIM, and post-market compliance. The role aligns with FDA/regulatory standards and interfaces with PLM, ERP, and manufacturing to enable closed-loop quality.

The incumbent will partner with Quality, Regulatory, R&D, Manufacturing, and IT leaders to create multi-year roadmaps,

Qualifications

• Bachelor’s degree or higher and domain knowledge in IT/quality/regulatory areas.
• Minimum 10 years’ experience in the assigned business domain.
• Minimum 7 years’ leadership experience with global scope.
• Agile certification preferred but not mandatory.

Responsibilities

• Own the global QA/RA solution portfolio and define strategy and data models.
• Lead, coach, and develop consultants, developers, analysts, and testers.
• Govern designs, configurations, integrations, and significant changes.
• Identify and mitigate risks; ensure regulatory compliance and lifecycle management.
• Partner with PO/architecture and delivery teams for end-to-end delivery.

Skills

Leadership

Communication

Project management

Business/technical acumen

Strategic thinking

Stakeholder collaboration

Education

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

Masters’s degree preferred

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 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

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

Solution Ownership & Strategy

• 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.

Governance, Risk & Compliance

• 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.

Continuous Improvement & AI

• 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:

• Masters’s degree preferred.
• Agile certification preferred but not mandatory.

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:

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive medical, dental, vision coverage effective on start date
• 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
• Paid Educational Assistance

*US Only

**Center Valley, PA and Westborough, MA

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.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Information Technology (IT)