Position Summary
Owns QMS process design, harmonization, and the operational excellence roadmap to ensure consistent, efficient, inspection-ready execution. Establishes standards, templates, and governance for core QMS processes and drives simplification and cycle-time reduction initiatives. Owns the Quality KPI framework and management review support materials, ensuring metrics are reliable and drive action. Leads adoption of best practices across the Quality organization and ensures QMS documentation remains current, controlled, and effective. Maintains readiness for audits and inspections through strong governance discipline and evidence control. Leads quality event trending and signal detection across the product lifecycle, ensuring meaningful insight generation and management review from Development QA through Commercial QA in support of lifecycle management, continuous improvement, and risk-based decision making within a virtual biotech operating model.

Key Responsibilities

QMS Design, Standards & Governance

• Own QMS architecture, process ownership model, and standards / templates, drive harmonization across teams / partners as applicable, including Development QA, IT QA, and Commercial QA interfaces across the product lifecycle
• Maintain SOP governance, periodic reviews, training impact requirements, document control, and training compliance across a virtual biotech organization, ensuring fit-for-purpose processes and inspection-ready records
• Produce deliverables such as QMS process maps, SOP governance calendars, standards / template libraries, lifecycle quality event trending reports, and training / document control dashboards

OPEX & Performance Management

• Lead OPEX portfolio (simplification, RFT, cycle time reduction) with benefits tracking and sustainment controls
• Own Quality KPI framework and cadence, Lead Quality Management Review coordination, Change Control Committees, quality event trending reviews, and support management review materials and action tracking
• Produce deliverables such as OPEX roadmap, benefits tracker, KPI pack, and management review decks

Inspection Readiness

• Ensure QMS documentation and evidence are audit / inspection-ready, drive remediation plans for gaps
• Maintain process narratives and consistency of execution across the organization
• Produce deliverables such as inspection readiness checklists, evidence indexes, and remediation trackers

Required Qualifications

• BS+ (Life Sciences, Engineering, Quality, or related)
• 18+ years Quality Systems / QMS (GxP) with audit support, lifecycle quality oversight from development through commercial operations, and measurable CI outcomes
• Demonstrated governance leadership and cross-functional influence, specifically through digitally focused initiatives

Preferred Qualifications

• Experience in pharmaceutical / biotech Quality Systems, global standards deployment, lifecycle management across Development QA to Commercial QA, and operating effectively within a virtual biotech environment (preferred)
• Proficient with Veeva Vault Quality / QMS, Quality Docs, and related quality system workflows including deviations, CAPA, change control, training, and document management

Key Competencies

• QMS architecture, process harmonization, and governance, SOP lifecycle management, quality event trending, document control, and training oversight
• Operational excellence leadership, KPI cadence facilitation, and benefits tracking, cycle-time and RFT improvement delivery
• Deep knowledge of Quality technology architecture and leading Quality solutions
• Advanced understanding of AI use cases in Quality and an ability to drive from strategizing to implementing these use cases and the key foundational prerequisites
• Understanding of data management leading practices to drive a consistent and connected Quality data foundation
• Change management (impact assessment, stakeholder mapping, communications, training / SOP readiness, adoption measurement) including full knowledge of IT QA controls, computerized system quality requirements, and training effectiveness expectations
• Cross-functional leadership, escalation, and executive-ready risk / decision communication
• Inspection readiness discipline, audit narrative readiness, evidence retrieval / traceability, and the ability to operate effectively in a virtual biotech organization

Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity, and a generous benefits package. Full-time employees are eligible for base salary, bonus, equity, and a comprehensive benefits suite.

Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs, and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $276,000 - $337,000 per year. We comply with all applicable minimum wage laws.

All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.