Director, Clinical and Quality Assurance

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 newly created Director role will build the company's Quality Management System (QMS) from the ground up - covering clinical assurance, audit readiness, data integrity, and AI governance. This person will be the organization's authoritative voice on quality and risk, partnering closely with Operations, Product, Data, Clinical, and Technology leaders to ensure every output is traceable, defensible, and audit-ready.

What You'll Do

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

• Build an AI-first quality strategy that uses automation and predictive analytics to scale quality operations efficiently

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

• Lead audit strategy, preparation, and response across client, regulatory, and third-party audits, maintaining an always-on inspection-ready posture

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

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

• Build and lead the QA organization, including hiring, career pathing, onboarding, and succession planning

• Drive cross-functional adoption of quality standards across Operations, Product, Data, and Technology without direct authority

• Chair the Pharmacy & Therapeutics (P&T) Committee, leading clinical decision governance

Basic Requirements

• Typically requires 12+ years of progressive experience in quality assurance, quality governance, or regulated operations, including 4+ years in a leadership role

• Demonstrated experience building or operationalizing an enterprise QMS from inception (policies, SOPs, controls, documentation governance)

• Experience leading audit strategy, preparation, execution, 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)

• Track record of leading multi-disciplinary teams within SaaS, healthcare technology, PBM, pharma, biotech, or another regulated healthcare environment

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

Preferred Skills/Experience

• Master's degree in a related field

• 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 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

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

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

Travel & Work Environment

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