Senior Associate Director, GMP Quality Release (API)

Madrigalpharma; Indiana (PA); On-site; USD 223,048 - 297,398; Full time

Job summary

Madrigal is seeking an Associate Director, GMP Quality Release (Quality API) to lead batch review and release across API and intermediate batches, ensuring consistent, compliant, and timely disposition. This role maintains release narratives, escalation pathways, and audit-ready documentation while coordinating with CMOs/CDMOs to protect supply continuity.

The position requires 10–12+ years in GMP pharma/biotech, with strong knowledge of ICH Q7, Q8–Q10, and experience in API release; DP

Qualifications

• BS or MSc in chemistry, chemical engineering, life sciences, or related field.
• 10–12 years GMP pharma/biotech experience with batch disposition leadership.

Responsibilities

• Own batch review and release standards, decision rights, and checklists for API/intermediates with DP cross-coverage.
• Lead disposition of commercial API and intermediates; provide DP release support as needed.
• Drive cycle-time, backlog management, and right-first-time performance across API release workflows.
• Coordinate review and resolution of release-blocking deviations, investigations, and documentation gaps with CMOs/CDMOs.
• Govern Batch Disposition in Veeva with audit-ready records and traceability.
• Partner with MSAT, Supply Chain, and Regulatory on release priorities and supply continuity.
• Mentor batch release staff and contribute to SOPs and process improvements.

Skills

Batch disposition governance

Cross-modality release

Veeva Vault Quality (eQMS)

Inspection readiness

External CMO management

Leadership

Release documentation

Risk-based decision making

Education

BS or MSc in a scientific discipline

Tools

Veeva Vault Quality (eQMS)

Job description

Madrigal is seeking an Associate Director, GMP Quality Release (Quality API) to lead batch review and release across API and intermediate batches, ensuring consistent, compliant, and timely disposition. This role maintains release narratives, escalation pathways, and audit-ready documentation while coordinating with CMOs/CDMOs to protect supply continuity.

The position requires 10–12+ years in GMP pharma/biotech, with strong knowledge of ICH Q7, Q8–Q10, and experience in API release; DP