Global GMP Quality Assurance Director

Mirum Pharmaceuticals, Inc.; Foster City (CA); On-site; USD 220,000 - 240,000; Full time

Job summary

Mirum Pharmaceuticals is seeking a Director of GMP Quality Assurance to lead global QA operations from development to commercial launch. You will ensure product quality, regulatory compliance, and continuous improvement across CSPs, with DSCSA, serialization, and GDP oversight.

The role requires deep GMP/GDP knowledge, collaboration across functions, and willingness to travel up to 20% to support audits and inspections worldwide.

Qualifications

• Bachelor’s degree in a scientific field required; advanced degree preferred.
• 10+ years in pharmaceutical/biotechnology; 8+ years GMP QA.
• Experience with clinical and/or commercial labeling and GDP requirements.
• Strong knowledge of FDA, EU GMP, ICH guidelines and DSCSA/serialization.
• Experience coordinating with CMOs, CTLs, 3PLs and regulatory bodies.

Responsibilities

• Provide worldwide QA oversight of FP, from development through commercialization.
• Oversee clinical and commercial distribution per GDP, DSCSA, serialization.
• Support labeling development, proofreading, and anti-counterfeiting activities.
• Lead investigations, change controls, risk assessments, and CAPA actions.
• Prepare, review, and approve tech transfer, validation, and expiry dating.
• Interface with regulators, auditors, and internal stakeholders; travel up to 20%.

Skills

Communication skills

Leadership

Problem solving

Risk management

Collaboration

Interpersonal skills

Education

Bachelor’s degree in science

MS or PhD preferred

10+ years pharma/biotech experience

Job description

Mirum Pharmaceuticals is seeking a Director of GMP Quality Assurance to lead global QA operations from development to commercial launch. You will ensure product quality, regulatory compliance, and continuous improvement across CSPs, with DSCSA, serialization, and GDP oversight.

The role requires deep GMP/GDP knowledge, collaboration across functions, and willingness to travel up to 20% to support audits and inspections worldwide.