Quality Assurance and Governance Lead

About the Role

Rx Savings Solutions (RxSS), part of McKesson's Prescription Technology Solutions segment, helps members, employers, and health plans lower medication costs, improve adherence, and navigate care. As RxSS scales toward a $150M revenue goal, this senior individual-contributor role operationalizes the company's Quality Management System (QMS) — covering clinical assurance, audit readiness, data integrity, and AI-enabled quality processes. This person carries formal governance authority to enforce quality standards, escalate risk, and recommend halting activities when compliance risk is present, and serves as the primary quality subject-matter expert to Operations, Product, Data, Clinical, and Technology teams.

What You'll Do

• Operationalize and maintain the end-to-end QMS, including policies, procedures, controls, and documentation governance (e.g., via MasterControl or similar eQMS platforms)

• Validate clinical assumptions behind algorithms, savings logic, and client configurations to keep ROI claims evidence-based and auditable

• Execute audit preparation, coordination, and response across client, regulatory, and third-party audits using repeatable frameworks and playbooks

• Manage deviation, investigation, CAPA, and quality-event processes, driving root-cause analysis and systemic improvement

• Define, track, and report quality KPIs (defect rates, audit findings, SLA adherence, savings-validation coverage) through executive dashboards

• Use AI-enabled monitoring and trend analysis to flag anomalies and proactively address risk before it materializes

• Exercise governance authority to enforce quality standards across teams, escalating non-compliance and flagging risk directly to leadership

• Author and maintain SOPs, control frameworks, escalation protocols, and audit response playbooks

Basic Requirements

• 4+ years of experience in quality assurance, quality governance, audit, compliance, or regulated operations

• Hands-on experience operationalizing a Quality Management System (QMS), including authoring and maintaining policies, SOPs, controls, and documentation governance

• Experience executing audit preparation, coordination, and response across client, regulatory, or third-party audits

• Experience evaluating clinical or algorithmic risk and translating findings into business terms (ROI, compliance, client trust)

• Demonstrated ability to drive cross-functional adoption of quality standards without direct authority

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Healthcare Administration, Information Systems, or a related field, or equivalent experience

Preferred Skills/Experience

• Experience in PBM, healthcare technology, benefits administration, or regulated healthcare services

• Experience with AI governance frameworks, including validation, risk classification, and control design for AI-enabled workflows

• Knowledge of FDA, ICH, GMP, SOC, or related regulatory and compliance frameworks

• Professional quality certification (ASQ CQA, CQE, or equivalent)

• Familiarity with Salesforce, JIRA, Tableau, Databricks, or similar platforms used in quality reporting and workflow management

• Strong executive communication skills, with the ability to translate QA risk into business impact for senior leadership

• Experience leveraging AI, automation, and data-driven approaches to improve quality processes and predictive risk management

Travel & Work Environment

Remote work is supported. Occasional travel (estimated less than 10%) may be required for audits or client meetings. This role involves standard office physical requirements, including extended periods of computer use.