Director, IT QA/RA Solutions - eQMS & RIM

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

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