Madrigal Pharmaceuticals
Executive Director, Quality Systems & Operational Excellence Lead
PA - Pennsylvania – Remote, USA · Director · Full-time
Sponsorship not specified$276k-$337kDetected 27 days ago
Product ManagementPerformance ManagementCadenceFDA RegulatoryLeadershipCommunicationGxP
About the role
- 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.
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
- 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
- Ensure QMS documentation and evidence are audit / inspection-ready, drive remediation plans for gaps
- Maintain process narratives and consistency of execution across the organization
Nice to have
- 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)
- Deep knowledge of Quality technology architecture and leading Quality solutions
- 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
- Key Competencies
- We comply with all applicable minimum wage laws.
- By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
- If you need assistance, please contact HR@madrigalpharma.com.
Compensation
- 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.
Benefits
- Lead OPEX portfolio (simplification, RFT, cycle time reduction) with benefits tracking and sustainment controls
- Produce deliverables such as OPEX roadmap, benefits tracker, KPI pack, and management review decks
Company info
- Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality.
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This listing is sourced directly from Madrigal Pharmaceuticals's careers page and normalized into a canonical job model.