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Job Summary

The AI Program Manager leads day to day execution of KLS Martin's enterprise AI program across all US business units. This role runs the AI governance framework, prioritizes use cases, drives pilots from concept through scaled production, and ensures all AI work meets the regulatory, security, and quality standards required of a medical device organization.

Working in close partnership with the AI Solutions Architect, this role translates business needs into a coordinated program of AI investment, enablement, and risk management.

The AI Program Manager partners with stakeholders across IT, business units, Quality, Regulatory, Legal, HR, Information Security, and the AI Solutions Architect to ensure AI initiatives deliver on their objectives while meeting applicable regulatory, quality, and security standards.

The AI Program Manager contributes to the continuous improvement of AI governance, intake, prioritization, training, and adoption processes, and develops AI literacy across the workforce through coordinated training, communications, and change management.

Essential Functions, Duties, and Responsibilities

• Maintain and evolve KLS Martin's AI framework, policies, and acceptable use guidelines.

• Operationalize the AI risk and ethics framework, including a risk taxonomy (hallucination, bias, data leakage, model drift, automation risk) and tiered review process for low, medium, and high risk use cases.

• Maintain the enterprise AI registry, the system of record for every AI tool and agent deployed at KLS, including ownership, data flows, and risk classification.

• Facilitate the AI Steering Committee and deliver regular reporting to executive leadership.

• Track emerging AI capabilities, vendor offerings, and industry practices, and recommend updates to the AI strategy, policies, and roadmap.

• Run the AI use case intake process, including scoring rubric, prioritization, and stage gates from idea through pilot to production.

• Partner with business units to identify, scope, and sponsor opportunities.

• Oversee pilots end to end with defined success criteria, exit conditions, and measurable business outcomes.

• Drive adoption planning, change management, and the scaling of validated solutions across the enterprise.

• Coordinate AI literacy and role specific training programs across the workforce.

• Develop and maintain communication channels (internal newsletter, lunch and learns, office hours) that build a culture of safe and effective AI use.

• Partner with HR on workforce impact, including how AI changes existing roles, required skills, and job design.

• Ensure alignment with IT, Information Security, Legal, Privacy, and Compliance on every initiative.

• Coordinate with Quality and Regulatory Affairs to determine when AI use cases trigger validation, design control, or notification requirements under ISO 13485 and FDA 21 CFR Part 820.

• Manage vendor relationships for AI tools, including evaluation, contracts, MSAs, DPAs, renewals, and offboarding.

• Manage acceptable use policy enforcement and exceptions handling.

• Coordinate cross functional response to AI incidents (data leakage, policy violations, public failures, regulatory inquiries), including stakeholder communication, post incident review, and corrective action tracking.

• Lead AI audit readiness and serve as the primary point of contact for internal and external audit inquiries related to AI systems, governance, and policy compliance.

• Serve as the primary liaison with KLS Germany on shared AI initiatives and information sharing across organizations.

• Partner with the AI Solutions Architect on technical feasibility, solution design, and delivery sequencing for approved use cases.

• Jointly own with the AI Solutions Architect the graduation criteria for moving prototypes into supported production, ensuring both technical readiness and business readiness.

• Serve as the translation layer between business stakeholders and the AI Solutions Architect, keeping technical work grounded in business value and stakeholder context.

• Define adoption KPIs and ROI metrics for each initiative.

• Track and report business value, productivity gains, and total cost (including AI vendor and API spend) to stakeholders.

• Manage the AI program budget, including forecasting, tracking, and reporting on AI vendor spend, API and model usage costs, training and enablement spend, and platform infrastructure costs.

• Perform other related duties as assigned.

Education and Experience Requirements

• Bachelor's degree in Business, Information Technology, Engineering, or a related field, or equivalent professional experience.

• 7+ years of program or product management experience, with at least 2 years leading AI, data, or digital transformation programs.

• Demonstrated experience working within governance frameworks in a regulated industry (medical device, pharmaceutical, biotechnology, finance, or similar).

• Strong working knowledge of enterprise AI capabilities (generative AI, agents, retrieval augmented generation, classification, automation) sufficient to evaluate proposals and challenge vendors.

• Proven ability to build relationships across IT, business units, legal, and compliance functions.

• Excellent written and verbal communication, including executive level briefing skills.

• Demonstrated experience managing program budgets, vendor contracts, and total cost reporting.

• Familiarity with ISO 13485, FDA 21 CFR Part 820, and HIPAA preferred.

• PMP, PgMP, or equivalent program management certification preferred.

• Background in formal change management methodologies preferred.

• Familiarity with major AI providers (Anthropic, OpenAI, Microsoft, Google) and their enterprise offerings preferred.

• Prior experience supporting internal or external audits in a regulated environment preferred.

• Familiarity with enterprise IT domains relevant to the role, including infrastructure, enterprise applications (ERP, HRIS, CRM, QMS), and cybersecurity preferred.

Knowledge, Skills, and Abilities

• Strong written and verbal communication skills, with the ability to influence peers, senior stakeholders, and external vendors.

• Ability to develop and maintain collaborative relationships across IT, business units, Quality, Regulatory, Legal, HR, Information Security, and external partners.

• Strong understanding of enterprise AI capabilities, including generative AI, agents, retrieval augmented generation, classification, and automation, sufficient to evaluate proposals and partner effectively with technical teams.

• Knowledge of AI governance, risk, and ethics practices, including risk taxonomies, review processes, and acceptable use frameworks.

• Knowledge of program and project management methodologies including waterfall, agile, and hybrid approaches.

• Ability to translate regulatory and quality requirements into practical program controls and operational practices.

• Ability to establish, monitor, and report on adoption KPIs, business value metrics, and program budget performance.

• Ability to proactively identify program risks, dependencies, and policy gaps and recommend mitigations.

• Strong analytical and problem solving skills with the ability to think strategically and operationally.

• Ability to evaluate program trade offs, prioritization, and resource allocation with incomplete information.

• Ability to manage multiple competing priorities under pressure and shifting business demands.

• Strong leadership skills with demonstrated ability to influence stakeholders and drive alignment across competing priorities without formal authority.

• Knowledge of vendor management practices including evaluation, contract review, SLA governance, and performance evaluation.

• Knowledge of change management principles and adoption planning practices.

• Strong writing skills with the ability to develop policies, executive status reports, business cases, and program documentation.

• Confidence in making independent as well as collaborative decisions as required by the situation.

• Ability to work effectively in both onsite and remote environments as required by the business.