Senior Director, API Quality Assurance & Compliance

Madrigal; Pennsylvania; Hybrid; USD 169,000 - 198,000; Full time

Benefits offered by this job

Flexible paid time off

Medical

Dental

Vision and life/disability insurance

401(k) offerings (i.e., traditional, 2

Supplemental life insurance

Legal services

Other offerings

Mental health benefits

Job summary

Madrigal is seeking a senior QA leader to oversee GMP API Quality Assurance and external partner oversight across CMOs/CDMOs. You will ensure ICH Q7 compliance, drive deviation/CAPA, and manage API batch documentation with strong risk-based controls.

Lead a cross-functional team, mentor API QA staff, and support health authority inspections. This role offers a comprehensive benefits package and equity opportunities.

Qualifications

• BS or MSc in a scientific discipline (Chemistry, Chemical Engineering, Pharmacy, or related)
• 10-12 years GMP pharmaceutical/biotech experience with significant focus on API quality and CMO oversight
• Demonstrated leadership in API batch disposition, deviation/CAPA, and change control governance
• Strong knowledge of ICH Q7, ICH Q8-Q11, FDA, EMA, and global API regulatory expectations
• Proven track record managing external API manufacturers and supporting health authority inspections

Responsibilities

• 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)
• Partner with MSAT/CMC on API control strategy evolution, validation readiness, and tech transfer to/from partners
• Ensure quality oversight across the API lifecycle, including PPQ, routine manufacturing, and post-approval changes
• Lead inspection readiness for API operations, including documentation, evidence packages, and audit response narratives
• Support FDA, EMA, and other health authority inspections related to API manufacturing and partner audits
• Drive trending and recurrence prevention for API quality events; deliver management review-ready insights
• Lead and mentor API QA staff and provide quality input on cross-functional governance forums

Skills

API quality governance

External partner oversight

ICH Q7 compliance

Inspection readiness

CAPA management

Education

BS or MSc in a scientific discipline

Tools

Veeva Vault Quality (eQMS)

Job description

Madrigal is seeking a senior QA leader to oversee GMP API Quality Assurance and external partner oversight across CMOs/CDMOs. You will ensure ICH Q7 compliance, drive deviation/CAPA, and manage API batch documentation with strong risk-based controls.

Lead a cross-functional team, mentor API QA staff, and support health authority inspections. This role offers a comprehensive benefits package and equity opportunities.