Quality Change Governance Lead

Madrigal; Pennsylvania; Hybrid; USD 164,000 - 201,000; Full time

Benefits offered by this job

Equity

Flexible PTO

Health insurance

401(k) with employer match

Mental health benefits

Job summary

Madrigal is seeking a Change Control Governance lead to own the change control standards, templates, and readiness criteria across Quality, CMC, MSAT, and Supply Chain. You will partner with internal teams and external partners to ensure risk-based decisions, timely execution, and inspection-ready documentation.

The role requires 10–12 years GMP QA/QMS experience, strong leadership, and deep knowledge of eQMS systems such as Veeva Vault.

Qualifications

• BS+ in Science / Engineering (or related).
• Demonstrated ability to lead cross-functional governance and risk-based decision making.
• Experience with change control governance in pharma/biotech is a plus.

Responsibilities

• Own change control standards, templates, decision rights, and review cadences.
• Coordinate change reviews across Quality / CMC / MSAT / Supply Chain and external partners.

Skills

Cross-functional leadership

Risk-based decision making

Project management

Effective communication

Education

BS in Science / Engineering

Tools

Veeva Vault Quality (eQMS)

Job description

Madrigal is seeking a Change Control Governance lead to own the change control standards, templates, and readiness criteria across Quality, CMC, MSAT, and Supply Chain. You will partner with internal teams and external partners to ensure risk-based decisions, timely execution, and inspection-ready documentation.

The role requires 10–12 years GMP QA/QMS experience, strong leadership, and deep knowledge of eQMS systems such as Veeva Vault.