Job Details

Quality Assurance Manager

This position collaborates closely with Clinical Supply Chain, CMC, Regulatory Affairs, Clinical Operations, and external partners to resolve quality issues, support timely release of Investigational Medicinal Products (IMPs), and maintain inspection readiness.

Qualifications and Experience
* Bachelor's degree in a scientific discipline, pharmaceutical sciences, or a related field; equivalent relevant experience may be considered.
* Typically 7+ years of experience in Pharmaceutical Quality Assurance, Quality Operations, or a related GMP-regulated function, including demonstrated experience supporting clinical packaging and labeling operations.
* Demonstrated experience reviewing and approving clinical packaging and labeling batch records and supporting documentation.
* Experience supporting clinical trial material release, IMP disposition, expiry extension assessments, temperature excursion investigations, and release restriction decisions.
* Strong working knowledge of GMP requirements applicable to Investigational Medicinal Products (IMPs), clinical packaging and labeling, and outsourced manufacturing operations.
* Experience managing or providing QA oversight of deviations, investigations, CAPAs, change controls, and documented product impact assessments.
* Experience working with external CMOs and pharmaceutical service providers.
* Experience with vendor quality oversight, audits, quality agreements, and inspection readiness preferred.
* Familiarity with electronic quality management systems and document management platforms.
* Experience supporting early-phase clinical development programs and managing competing clinical supply priorities preferred.
* Strong technical writing, documentation review, and risk assessment skills.
* Sound judgment and the ability to make timely, scientifically justified, risk-based quality decisions.
* Demonstrated leadership and influencing skills in a matrixed environment.
* Strong organizational and project management skills, with the ability to manage multiple priorities and time-sensitive clinical supply activities.
* Effective communication and collaboration skills with internal stakeholders and external partners. The role requires effective coordination with external manufacturing, packaging, labeling, storage, and distribution partners, as well as close collaboration with Clinical Supply Chain, CMC, Regulatory Affairs, Clinical Operations, and Quality. Periodic domestic travel may be required to support vendor oversight, on-site packaging and labeling activities, audits, inspections, and other quality initiatives.