Director of Quality
The Director of Quality is responsible for building and leading a fit-for-purpose, phase-appropriate Quality Management System (QMS) for Halia Therapeutics. This role will oversee GxP quality activities, develop and enforce policies and SOPs that comply with US FDA, Australian TGA, EU EMA, Indian CDSCO, and UAE Ministry of Health regulations, manage vendor quality, and ensure audit readiness across the organization.
Key Responsibilities
· Design, implement, and maintain a scalable, phase-appropriate Quality Management System (QMS).
· Develop, maintain and enforce quality policies, SOPs, templates, and controlled documents.
· Ensure GxP compliance across multi-national GCP, GLP, GMP, and other applicable areas. It may be implied under GCP: consider mentioning TMF oversight ensuring completeness/accuracy/integrity of TMF + clinical data; same for GLP, it may be implied: consider data integrity and equipment validation (Utah Lab)
· Create and manage the company-wide training program, including role-based curricula and compliance tracking.
· Lead vendor qualification, auditing and performance reviews for CROs, CMOs, labs, and other suppliers.
· Develop and execute annual internal and external audit plans.
· Ensure timely resolution of audit findings, deviations (including GDP-Good Documentation Practice), CAPAs, and change controls.
· Support inspection readiness and host regulatory inspections as needed.
· Establish quality metrics and dashboards for leadership reporting.
· Manage QDs budget, collaborate w leadership embedding quality into company’s development strategy
· Cross-functional collaboration (ClinOps, Reg Affairs, R&D, leadership)
· Other duties as assigned
Qualifications – Required
· Bachelor’s degree in Life Sciences, or related field.
· 10+ years of experience in pharmaceutical or biotech Quality roles.
· Experience building or scaling a QMS in a small or growing company.
· Strong knowledge of GxP regulations (GCP, GLP, GMP); global regulatory exposure
· Demonstrated experience authoring SOPs and leading audits.
· Strong communication and collaboration skills across cross-functional teams.
· Proven experience to lead/mentor teams
Preferred Qualifications
Advanced degree (MS, PhD, PharmD).
Experience implementing an electronic QMS (eQMS).
Experience hosting regulatory inspections.
Quality certifications (e.g., ASQ, RAC).
Ths is an onsite position in Lehi, Utah and relocation assistance will not be available.
Salary Range $170,000 --$200,000