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 Manager Quality Compliance position supports and ensures compliance with GxP standards, including Good Clinical Practice (GCP), Good Distribution Practices (GDP), Good Documentation Practices (GdocP), Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP) and Good Pharmacovigilance Practices (GPvP) as applied to the product lifecycle, from research and development, clinical phases and commercial launch and on-going commercial quality support. This position serves as the in-office Quality presence in the corporate office and will coordinate with quality colleagues working remotely.
Principle Duties and Responsibilities Include:Inspection Readiness and Management and Support of Regulatory Inspections (example clinical, preapproval and routine inspections)Provide technical quality and/or strategic support to clinical sites and service provider sites to ensure inspection readiness and pre-approval inspections.Lead and participate in mock inspections, internal audits, and other readiness activities. Lead and support during the preparation, execution, and closure of health authority inspections. Provide the Quality representation in the Redwood City office to receive unannounced health authority inspections.Support design, training, and execution of GxP inspection management processes and procedures in collaboration with internal and external teams to ensure a state of inspection readiness. Work internally or externally to manage regulatory inspection responses within required time frames.Service Provider Program/External and Internal AuditsDevelop and maintain an annual risk-based audit schedule for external service providers. Ensure adherence to the schedule and completion of all required documentation per procedures.Lead and maintain periodic review of all service providers.Lead GxP Audits, ensuring compliance with applicable regulations/guidelines and quality agreements. Development and implement audit plans/agendas, draft and review audit reports, work with providers for review and acceptance of audit responses.Maintain the approved vendor list.Negotiate and approve Quality Agreements and related documents.Maintain tracking for all arms of the program and report key KPIs. Support and manage the GxP internal and audit processes and procedures that govern the programs.Evaluate internal and external audit findings and ensure timely identification and escalation of potential critical observations and compliance gaps are escalated to senior leadership. Support the cross functional teams to ensure remediation.Rezolute (RZLT) currently anticipates the base salary for the Sr Manager Quality Compliance role could range from $165,000 to $180,000 and will depend, in part on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.
Qualifying employees are eligible to participate in benefit programs such as:
· Health Insurance (Medical / Dental / Vision)
· Disability, Life & Long-Term Care Insurance
· Holiday Pay
· Tracking Free Vacation Program
· 401(k) Plan Match
· Educational Assistance Benefit
· Fitness Center Reimbursement
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.