Senior Director, GMP Quality Assurance

MISSIONMirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

POSITION SUMMARY The Senior Director, GMP Quality is responsible for the global oversight and management of GMP Quality Assurance operations supporting development and commercial programs. The role manages multiple complex priorities, provides technical and compliance leadership, resolves quality issues, and collaborates cross-functionally with internal stakeholders and external partners to support product quality, regulatory compliance, and continuity of clinical and commercial supply.

The position primarily provides oversight of clinical and commercial Good Distribution Practice (GDP) activities, including compliance with applicable U.S., EU/UK, and other global GDP requirements including the U.S. DSCSA, serialization, track-and-trace, and exception management requirements. The Senior Director is accountable for the quality and timely delivery of activities within the role’s scope.

JOB FUNCTIONS/RESPONSIBILITIES Provide QA oversight of finished product (FP), from early development through commercialization.

Provide QA oversight of clinical and commercial product distribution activities in accordance with applicable GDP requirements, DSCSA, serialization, track-and-trace, and exception management requirements as appropriate.

Support the development and approval of commercial labeling, including prepress activities, proofreading of labeling artwork, and anti-counterfeiting activities.

Perform lot disposition activities, including batch record review; review of in-process, release, and stability testing; and assessment of quality events associated with GMP products and processes.

Provide QA oversight across the product development lifecycle, including drug substance (DS) and drug product (DP) from early development through commercialization.

Review and approve protocols and reports related to technology transfer, process validation, method transfer, method qualification and validation, and expiry dating, as applicable.

Lead quality-related discussions, investigations, risk assessments, and change controls to ensure potential product quality issues are appropriately evaluated, addressed, documented, and justified.

Provide technical expertise and guidance for internal and external deviations, laboratory investigations, change controls, and related quality events; ensure appropriate tracking, follow-up, and timely resolution in collaboration with responsible functions and external partners.

Author, review, and negotiate Quality Agreements with GxP vendors, intra-company sites, alliance partners, and investigator-sponsored trial (IST) partners, as applicable.

Author, coordinate the preparation, review, approval, and timely completion of Annual Product Reviews/Product Quality Reviews (APR/PQRs), as applicable.

Perform compliance gap assessments, identify appropriate remediation actions, and drive implementation to completion.

Communicate manufacturing deficiencies and nonconformances to management and work with external partners to ensure timely and effective resolution.

Review and support regulatory and quality documentation for submissions, including INDs, CTAs, IMPDs, NDAs, and MAAs, as applicable.

Interface with regulatory authorities, host third-party GMP audits, and support CMO pre-approval inspections (PAIs) and other regulatory inspections, as needed.

Champion continuous…