Sr. Quality Specialist

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)
 The Sr. Quality Specialist at Rezolute is a dedicated Quality professional responsible for assuring the GxP quality requirements supporting the product development, phase appropriate and proportionate lifecycle management of clinical products, and commercialization, launch and ongoing commercial supply of ersodetug. The Sr. Quality Specialist is a hands-on individual contributor and core member of the Quality team. In partnership with other functional areas (MSAT, Supply Chain, and R&D), the Sr. Quality Specialist will develop and execute quality deliverables supporting CMC strategies, including identification and escalation of risks. This includes, but not limited to, partnering with CMC to ensure that product is manufactured and released according to internal standards and regulatory requirements.
 The Sr. Quality Specialist is a specific role within Rezolute’s Quality organization and performs key activities to support Quality Assurance processes specific to the product development plan for Rezolute’s clinical phase programs, the qualification and validation of commercial processes, and responsible for product disposition.  This role is a team partner for activities, including, but are not limited to, Change Controls, Vendor Qualification, Deviations, CAPAs, product disposition, Process and Analytical Qualification and Validation, Technical Transfer, Product Complaints, Continuous Process Validation, Regulatory Agency Reporting, and Pharmacovigilance.   

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 support for the Quality oversight to ensure product is manufactured, tested, stored, and distributed according to cGMPs and other applicable regulations.
• Responsible for ensuring drug substance and 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
• Provides Quality assessments for Change Controls
• Provide Quality review/approval of clinical and commercial Labeling & Artwork
• Provides technical quality and/or strategic support to sites during product vendor qualification audits, pre-approval inspections, and routine GMP inspections as required

Qualifications and Requirements –

• Minimum of Bachelor’s degree in a scientific discipline with 5 to 7 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, and Adobe Acrobat

Rezolute (RZLT) currently anticipates the base salary for the Sr. Quality Specialist role could range from $120,000 to $140,000 and will depend, in part on the successful candidate’s geographical location a