Working Location: Pennsylvania, Center Valley; Massachusetts, Westborough

Workplace Flexibility: Hybrid

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

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 in this location is $144,541.00 - $216,812.00 / year, plus potential for annual bonus (subject to plan eligibility and other 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.

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