Manager, Quality Assurance
Job Location:
Redwood City, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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.
Rezolutes 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
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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 Rezolutes 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.
- 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 distribution of commercial product 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 Rezolutes 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
- Provides Quality support for commercial packaging and distribution qualifications validations and operations including serialization.
- 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 postmarketing requirements.
- Minimum of Bachelors 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
Rezolute (RZLT) currently anticipates the base salary for the Manager of Quality Assurance role could range from $140000 to $165000 and will depend in part on the successful candidates 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 Companys 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.
Required Experience:
Manager
About Company
Rezolute is a clinical‑stage biopharmaceutical company developing transformative therapies—such as the monoclonal antibody ersodetug (RZ358) in Phase 3 for congenital hyperinsulinism and the oral plasma kallikrein inhibitor RZ402 in Phase 2 for diabetic macular edema—to treat rare met ... View more
