Remote Associate Director, API Quality Assurance

Madrigal Pharmaceuticals, Inc.; United States; On-site; USD 169,000 - 198,000; Full time

Benefits offered by this job

Equity / stock options

Flexible PTO

401(k) with match

Job summary

Madrigal Pharmaceuticals, Inc. seeks an Associate Director of API Quality Assurance (GMP) to lead the quality strategy for API and intermediates across external CMOs/CDMOs. You will ensure ICH Q7 compliance, drive CAPA, and maintain inspection readiness while partnering with MSAT/CMC teams.

The role requires a strong track record in API QA, external manufacturing oversight, and readiness for FDA/EMA inspections, with leadership of QA staff and cross‑functional governance forums.

Qualifications

• BS/MS in a scientific discipline with GMP experience preferred.
• 10–12 years GMP pharma/biotech API quality and CMO oversight experience.
• Proven track record in API batch disposition, deviation/CAPA, and change control governance.
• Experience supporting health authority inspections (FDA/EMA) and external manufacturing networks.

Responsibilities

• Own GMP API QA strategy, governance, and standards across external API manufacturers.
• Lead quality oversight of API and intermediate manufacturing at CMOs/CDMOs for ICH Q7 compliance.
• Oversee API batch record review quality, documentation rigor, and traceability of decision rationale.
• Drive deviation impact assessment, RCA rigor, CAPA linkage, and verification of effectiveness.

Skills

API QA leadership

GMP compliance

ICH Q7 knowledge

External partner oversight

Deviation/CAPA management

Change control governance

Veeva Vault Quality

Education

BS in science

MS/PhD (preferred)

Tools

Veeva Vault Quality

Job description

Madrigal Pharmaceuticals, Inc. seeks an Associate Director of API Quality Assurance (GMP) to lead the quality strategy for API and intermediates across external CMOs/CDMOs. You will ensure ICH Q7 compliance, drive CAPA, and maintain inspection readiness while partnering with MSAT/CMC teams.

The role requires a strong track record in API QA, external manufacturing oversight, and readiness for FDA/EMA inspections, with leadership of QA staff and cross‑functional governance forums.