Director, Quality Assurance
Mirum Pharmaceuticals, Inc.
August 31, 2026
Remote friendly (Foster City, CA)
United States
Operations
Position Summary
The Director, Quality Assurance provides global oversight and management of GMP Quality Assurance operations supporting development and commercial programs, including technical/compliance leadership, resolution of quality issues, cross-functional collaboration, and oversight of product quality, regulatory compliance, and continuity of clinical/commercial supply. Oversees clinical and commercial GDP activities, including U.S., EU/UK, and global GDP requirements (including U.S. DSCSA, serialization, track-and-trace, and exception management).
Responsibilities
- Provide QA oversight of finished product (FP) and of drug substance/drug product (DS/DP) across the development lifecycle.
- Oversee clinical and commercial distribution activities under applicable GDP/DSCSA/serialization/track-and-trace/exception management requirements.
- Support commercial labeling development/approval (prepress, proofreading, anti-counterfeiting).
- Perform lot disposition (batch record review; in-process/release/stability testing; assess quality events).
- Review/approve protocols and reports for technology transfer, process validation, method transfer/qualification/validation, and expiry dating.
- Lead investigations, risk assessments, and change controls; ensure quality issues are evaluated, addressed, documented, and justified.
- Provide technical guidance for deviations, laboratory investigations, and quality events; ensure tracking and timely resolution.
- Author/review/negotiate Quality Agreements with GxP vendors/sites/partners/IST partners.
- Prepare/review/approve APR/PQRs (as applicable).
- Conduct compliance gap assessments and drive remediation to completion.
- Communicate manufacturing deficiencies/nonconformances and ensure timely resolution.
- Support regulatory submissions and documentation (IND, CTA, IMPD, NDA, MAA) and inspections (including PAIs).
- Interface with regulatory authorities and host third-party GMP audits; support CMO pre-approval inspections.
- Champion continuous improvement initiatives.
- Travel up to 20% (including international).
Qualifications
- Bachelor’s degree in a scientific discipline required; MS/PhD preferred.
- 10+ years in pharma/biotech; 8+ years in GMP Quality Assurance.
- Required: experience in clinical and/or commercial labeling and last-mile commercial operations.
- Strong knowledge of global GMP/GDP (FDA, EU GMP EudraLex Vol 4, ICH) and clinical/commercial distribution requirements.
- Demonstrated experience from early development through global commercialization.
- Strong CMC/process validation/technology transfer knowledge and small-molecule manufacturing exposure.
- Regulatory submission and health authority inspection experience (including PAIs).
- Experience overseeing international CMOs, CTLs, CPOs, 3PLs, and distributors.
- Preferred: global serialization/track-and-trace and DSCSA exception management.
- Excellent communication, collaboration, leadership, problem-solving, and risk management skills.
Compensation
- Salary range: $220,000–$240,000 USD (base salary only as stated).
Travel
- Up to 20% (including international).
The Director, Quality Assurance provides global oversight and management of GMP Quality Assurance operations supporting development and commercial programs, including technical/compliance leadership, resolution of quality issues, cross-functional collaboration, and oversight of product quality, regulatory compliance, and continuity of clinical/commercial supply. Oversees clinical and commercial GDP activities, including U.S., EU/UK, and global GDP requirements (including U.S. DSCSA, serialization, track-and-trace, and exception management).
Responsibilities
- Provide QA oversight of finished product (FP) and of drug substance/drug product (DS/DP) across the development lifecycle.
- Oversee clinical and commercial distribution activities under applicable GDP/DSCSA/serialization/track-and-trace/exception management requirements.
- Support commercial labeling development/approval (prepress, proofreading, anti-counterfeiting).
- Perform lot disposition (batch record review; in-process/release/stability testing; assess quality events).
- Review/approve protocols and reports for technology transfer, process validation, method transfer/qualification/validation, and expiry dating.
- Lead investigations, risk assessments, and change controls; ensure quality issues are evaluated, addressed, documented, and justified.
- Provide technical guidance for deviations, laboratory investigations, and quality events; ensure tracking and timely resolution.
- Author/review/negotiate Quality Agreements with GxP vendors/sites/partners/IST partners.
- Prepare/review/approve APR/PQRs (as applicable).
- Conduct compliance gap assessments and drive remediation to completion.
- Communicate manufacturing deficiencies/nonconformances and ensure timely resolution.
- Support regulatory submissions and documentation (IND, CTA, IMPD, NDA, MAA) and inspections (including PAIs).
- Interface with regulatory authorities and host third-party GMP audits; support CMO pre-approval inspections.
- Champion continuous improvement initiatives.
- Travel up to 20% (including international).
Qualifications
- Bachelor’s degree in a scientific discipline required; MS/PhD preferred.
- 10+ years in pharma/biotech; 8+ years in GMP Quality Assurance.
- Required: experience in clinical and/or commercial labeling and last-mile commercial operations.
- Strong knowledge of global GMP/GDP (FDA, EU GMP EudraLex Vol 4, ICH) and clinical/commercial distribution requirements.
- Demonstrated experience from early development through global commercialization.
- Strong CMC/process validation/technology transfer knowledge and small-molecule manufacturing exposure.
- Regulatory submission and health authority inspection experience (including PAIs).
- Experience overseeing international CMOs, CTLs, CPOs, 3PLs, and distributors.
- Preferred: global serialization/track-and-trace and DSCSA exception management.
- Excellent communication, collaboration, leadership, problem-solving, and risk management skills.
Compensation
- Salary range: $220,000–$240,000 USD (base salary only as stated).
Travel
- Up to 20% (including international).