Global GMP Quality VP: Strategy & Compliance Leader

Mirum Pharmaceuticals, Inc.; Foster City (CA); On-site; USD 320,000 - 340,000; Full time

Job summary

Mirum Pharmaceuticals, Inc. is seeking a VP, Global GMP Quality to lead GMP QA and QC at Mirum and its subsidiaries (US and international).

You will drive a quality culture, align GMP/GDP programs with strategic goals, mentor teams, and oversee product release, regulatory inspections, CAPA, and recall activities in a fast-growing rare-disease biopharma environment. The ideal candidate has 15+ years in QA, with 10+ in leadership, deep CMC knowledge, and a proven track record with FDA/EMA

Qualifications

• 15+ years of progressive Quality Assurance experience in pharmaceutical/biotech.
• 10+ years in quality leadership with direct & indirect reports.
• Extensive knowledge of cGMP manufacturing and Quality Management (FDA/EMA).
• Experience with inspection readiness and regulatory inspections (FDA/EMA/MHRA/EMA).
• Ability to lead cross-functional teams across multiple regions and functions.

Responsibilities

• Lead GMP QA and QC functions for clinical and commercial products.
• Develop global GMP quality strategy aligned with regulatory requirements.
• Oversee regulatory inspections, CAPA plans, and recalls.
• Mentor QA/QC teams and drive continuous improvement across GMP/GDP.
• Collaborate with senior leadership to meet corporate objectives.

Skills

Quality leadership

GMP compliance

Regulatory liaison

Audits

Cross-functional leadership

Education

Bachelor’s degree in biology/chemistry/biochemistry

Advanced degree preferred

Job description

Mirum Pharmaceuticals, Inc. is seeking a VP, Global GMP Quality to lead GMP QA and QC at Mirum and its subsidiaries (US and international).

You will drive a quality culture, align GMP/GDP programs with strategic goals, mentor teams, and oversee product release, regulatory inspections, CAPA, and recall activities in a fast-growing rare-disease biopharma environment. The ideal candidate has 15+ years in QA, with 10+ in leadership, deep CMC knowledge, and a proven track record with FDA/EMA