Senior Manager, GMP Quality Assurance

Madrigal Pharmaceuticals

23h

About The Position

This role is a key member of the Quality Assurance team, responsible for quality oversight of external GMP manufacturers (CMOs/CDMOs) supporting commercial drug substance, drug product, and finished product. This individual serves as the primary quality liaison across internal functions (e.g., MSAT, Supply Chain, Regulatory) and external partners to ensure compliance with global regulatory requirements and Madrigal’s Quality Management System. The Senior Manager is expected to drive quality strategy, enable risk-based decision-making, and lead continuous improvement initiatives and lead GMP batch disposition for an expedited portfolio to enable timely, compliant release decisions that protect patient safety and ensure supply continuity. Establishes review standards, cycle-time expectations, and escalation pathways for exceptions, ensuring decisions are risk-based, consistent, and well documented. Partners with Manufacturing/CMOs, Quality Operations, and Supply Chain to improve right-first-time documentation and reduce disposition cycle time. Maintains inspection readiness through strong documentation control, traceable decision rationales, and clear release narratives. Drives continuous improvement to reduce recurring documentation errors and ensures timely deviation management to ensure continuous supply. This position provides end-to-end quality oversight across the commercial supply chain, including batch disposition, external quality event management, and inspection readiness.

Requirements

BS or MSc in a scientific discipline, with at least 7 years of experience in GMP pharmaceutical/biotech manufacturing, including disposition / release or quality operations and oversight of external CMOs/CDMOs for commercial products
Candidate should have experience managing commercial external manufacturers and QA review of batch documentation and quality events
Must have strong interpersonal, negotiation, presentation, and communication skills
Strong knowledge of design, development, and/or reviews of QA standards and procedures (i.e., policy documents and SOPs)
Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications
Knowledge of FDA regulations and ICH Guidelines in the pharmaceutical and/or biotech manufacturing environment
Knowledge of risk management.
Ability to make rational, timely, and compliant risk-based decisions
Strong deviation impact assessment capability and documentation rigor
Skilled in developing collaborative internal and external relationships

Nice To Haves

Experience with Veeva Quality/Docs and Veeva QMS modules is highly desirable
Experience in pharmaceutical / biotech manufacturing networks and external manufacturing batch release interfaces (preferred)
Experience supporting inspections with batch disposition narratives and evidence packages

Responsibilities

Lead batch record review strategy and ensure consistent, compliant, well-documented release decisions
Leads the review and disposition of commercial batch records for API intermediates, API, drug product, and finished product
Own quality oversight of external manufacturers, including performance trending and governance
Ensure quality oversight across the commercial product lifecycle, including PPQ, routine manufacturing, and post-approval changes
Ensure effectiveness of Quality Agreements
Drive management and resolution of deviations and change controls with contractors and CMOs.
Assess impact of deviations and changes on product quality and compliance
Oversee documentation and closure of external deviations and change control in the QMS
Maintain inspection-ready disposition evidence packages and support audit responses
Drive right-first-time documentation improvements with Ops / CMOs to reduce repeat errors and delays
Produce deliverables such as RFT and SOP/WI updates to ensure compliance
Make risk-based quality decisions impacting product disposition and supply continuity
Owns and drives the Batch Disposition process within Veeva
Provide quality oversight of late stage / clinical manufacturing activities supporting commercial supply, as applicable
Escalate and manage critical quality risks impacting product supply or compliance
Support internal and external audits/inspections as requested.
Support responses to FDA, EMA, and/or other health authority inspections
Ensures compliance to applicable regulations, including U.S. and global health authorities
Provide quality leadership and influence cross-functional decision making to ensure compliant and efficient supply of commercial products