Madrigal Pharmaceuticals

QA Engineer

• Own GMP API Quality Assurance strategy, governance cadence, and standards across external API manufacturers
• Lead quality oversight of API and intermediate manufacturing at CMOs/CDMOs, ensuring ICH Q7 and global GMP compliance
• Set expectations for API batch record review quality, documentation rigor, and decision rationale traceability
• Drive deviation impact assessment, RCA rigor, CAPA linkage, and effectiveness verification for API quality events
• Oversee change control review and approval for API processes, specifications, methods, and partner-initiated changes
• Maintain quality agreements with API CMOs and lead performance governance routines (KPIs, scorecards, QBRs)

Associate Director, API Quality Assurance – GMP

Administration

• Prepare, review, process, and administer a variety of agreements, including confidentiality agreements, consulting agreements, vendor and service agreements, statements of work, master service agreements, and amendments.
• Coordinate contract routing, review, and approval workflows with internal stakeholders.
• Support contract execution activities and ensure all required documentation is complete and properly maintained.
• Maintain contract records, templates, amendments, renewals, and related documentation within the contract lifecycle management system.
• Monitor contract status, key dates, expiration timelines, and deliverables.
• Assist internal stakeholders with contract-related questions, documentation requests, and process guidance.
• Ensure contracts comply with company policies, procedures, and approval requirements.
• Escalate contractual issues or non-standard terms to Legal or management as appropriate.
• Assist with maintaining standard templates, clause libraries, and contract administration procedures.
• Support audits, inspections, and compliance-related activities involving contract documentation.
• Prepare reports and maintain accurate contract metrics and tracking information.
• Maintain confidentiality and handle sensitive information with professionalism and discretion.

Senior Contracts Administrator

Supply Chain

• Leads supply chain operational excellence and digital enablement to standardize best practices and improve execution performance across global teams
• Owns a continuous improvement pipeline with disciplined intake, prioritization, delivery, and benefits tracking
• Partners with IT / Analytics to simplify processes, automate workflows, and improve execution visibility through consistent metrics and reporting
• Builds standard work, SOPs, and performance routines that reduce variability and improve plan-to-execution reliability
• Ensures improvements are sustained through training, coaching, and controls

Director, Global Supply Chain Excellence – Digital Enablement Lead

Operations

• Directing, monitoring, and enhancing specialty pharmacy operations within Madrigal’s Market Access and Trade team
• Managing dispensing operations across the channel to drive continuous improvement in patient access and adherence
• Collaborating with internal stakeholders including MPS, Marketing, Data Analytics, Medical Affairs, Finance, Pricing & Contracting, Regulatory, Legal, and Market Access field team
• Engaging external stakeholders in day-to-day program operations and analysis of key data and KPIs
• Developing and implementing operational structures to support Madrigal’s specialty pharmacy network strategy
• Overseeing brand planning initiatives, operational plans, project budgets, expenses, and timelines
• Ensuring timely and accurate reporting of Adverse Events received through SP network

Director, Specialty Pharmacy Operations

Compliance

• Serve as a Compliance Business Partner to Commercial, Patient Advocacy, and Patient Support Services
• Provide compliance review and oversight of key activities, including healthcare professional engagements
• Advise on business initiatives through legal and compliance frameworks
• Support the development and delivery of compliance training and communications
• Conduct third-party risk management activities, including due diligence and risk assessment
• Participate in governance activities, including grant committees and business reviews
• Support compliance monitoring, risk assessment, and investigation activities
• Contribute to the development and continuous improvement of compliance policies and procedures

Senior Director, Compliance Business Partner

Director

• Leads GCP quality oversight for global clinical program(s) to ensure sustained compliance, inspection readiness across internal teams.
• Implements standards for risk-based oversight, issue management rigor, translating quality signals into cross-functional actions that protect participants and data integrity.
• Oversees quality performance across a portfolio of programs and studies, ensuring measurable recurrence reduction.
• Provides executive-ready reporting on quality risks, trends, and readiness.
• May lead/mentor GCP quality staff.

Associate Director, API Quality Assurance – GMP

Senior Contracts Administrator

Director, Global Supply Chain Excellence – Digital Enablement Lead

Director, Specialty Pharmacy Operations

Senior Director, Compliance Business Partner

Associate Director, GCP Quality Oversight