Manager, Quality Assurance

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.

Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders

More information can be found at rezolutebio.com

 

Position Description

 

The Manager, Quality Assurance at Rezolute is a dedicated Quality professional responsible for managing GxP quality requirements supporting product development, phase appropriate and proportionate lifecycle management of clinical products, and the commercialization, launch, and ongoing commercial supply of ersodetug. The Manager, Quality Assurance is a hands-on core member of the Quality team and plays a critical role across the product lifecycle from clinical development through post approval commercialization.

 

In partnership with other functional areas (including MSAT, Supply Chain, R&D, Regulatory Affairs, Pharmacovigilance, Sales, and Marketing), the Manager, Quality Assurance will develop and execute quality deliverables supporting CMC and commercial strategies, including the identification, assessment, and escalation of quality and compliance risks. This includes, but is not limited to, partnering with CMC and Commercial Operations to ensure that product is manufactured, released, distributed, promoted, and monitored in compliance with internal standards and applicable global regulatory requirements.

 

The Manager, Quality Assurance is a key contributor within Rezolute’s Quality organization and supports Quality Assurance processes for clinical stage programs, validation and qualification of commercial processes, product disposition, and post approval lifecycle management. This role also provides quality oversight for commercial activities, including support of sales and marketing materials, vendor and distributor oversight, product complaints investigations, and regulatory agency commitments following product approval.