Manager, Quality Assurance

Company Description Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI). Rezolute has received orphan drug designation in the United States and European Union as well as a rare pediatric disease designation, for ersodetug, enabling eligibility for a priority review voucher. More information can be found at rezolutebio.com

Position Description

Overview: 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.

Principle Duties and Responsibilities:

• Review and approval of Master Production Records from Contract Manufacturing Organizations to include Drug Substance manufacturing, Drug Product manufacturing, Finished Drug Product labeling and packaging operations, and External Laboratory Oversight.
• Review of executed records and final Product Disposition of product intended for supply of clinical trials, extended access programs, and commercial supply.
• Provides the Quality oversight to ensure product is manufactured, tested, stored, and distributed according to cGMPs and other applicable regulations.
• Responsible for ensuring drug substance, drug product, and finished drug product, is dispositioned to meet Rezolute’s timelines, including labeling and packaging records.  Interacts with CMOs and Qualified Persons to ensure timely release of product in ex-US territories
• Attends, participates in, and contributes to CMC team meetings
• Reviews and/or approves methods, procedures, master records, executed records, reports and protocols employed in the conduct of cGMP activities
• Authors new or revisions to quality systems SOPs and work instructions to support quality functional activities.
• Reviews and approves production batch records, certificates of analysis, client notifications, specifications, qualifications, investigations, deviations, CAPA, certificates of origin, and certificates of conformance
• Provide Quality assessments and approvals for Change Controls impacting clinical or commercial products, processes, labeling, or distribution.
• Provide Quality review/approval of clinical and commercial Labeling & Artwork
• Provides technical quality and/or strategic support to sites during product service provider qualification audits, pre-approval inspections, and routine GMP inspections as required.
• Support post approval commitments, variations, and lifecycle management activities in collaboration with QA Compliance, Regulatory Affairs and CMC.
• Support Continuous Process Verification/Validation and ongoing commercial process monitoring activities.
• Contribute to inspection readiness activities and responses to regulatory agency questions, commitments, and post‑marketing requirements.

Qualifications/Requirements:

Minimum of Bachelor’s degree in a scientific discipline with five to seven years’ experience in a cGMP regulated pharmaceutical/biotech environment

• Strong knowledge of appropriate Quality Systems and cGMPs (FDA, EU, ICH) with the ability to assess compliance risks
• Demonstrated ability to work independently and remotely, prioritize, problem-solve and complete activities in a timely manner without daily direction from the Head of Quality or others.
• Strong verbal skills, technical writing skills and ability to work with others in a collaborative manner.
• Ability to anticipate and mitigate challenges and apply a flexible risk-based approach to problem solving
• Experience with Microsoft Office is preferred

Preferred Experience, Special Skills and Knowledge -

 

• Expertise and hands-on knowledge of GMPs
• Entrepreneurial, innovative, analytical, and solution-minded
• Proficiency in SharePoint, MS-Word, Excel, PowerPoint, Adobe Acrobat, and Veeva