Quality Control Sample Manager (Contractor)

Adverum Biotechnologies, Inc., wholly owned subsidiary of Eli Lilly and Company, is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.
Note to Recruiters and AgenciesAll recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team.  Unsolicited resumes sent to Adverum will be considered Adverum's property.   Adverum’s Talent Acquisition team must expressly engage agencies for any requisition.  Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.
Adverum is looking for a Quality Control Sample Manager to join our team in our Redwood City office. This position reports to the Quality Control Senior Advisor.  The QC Sample Manager works cross‑functionally with QC, QA, Manufacturing, Supply Chain, and external partners to maintain robust systems and processes that ensure timely and accurate sample flow.This individual will be a crucial member of the Quality Control team, contributing to the development and performance Quality Control (QC) methods, systems, policies, processes, procedures and controls as they relate to the analytical testing of clinical materials. 

What You’ll Do:

• Oversee end‑to‑end QC sample lifecycle: receipt, login, labeling, inventory creation, storage, distribution, shipment, and disposition.
• Maintain accurate sample inventories for in‑process materials, raw materials, retains, stability samples, reference standards, and controls.
• Support and address sample‑management-related audit observations; implement corrective and preventive actions (CAPAs).
• Perform weekly lab audits using standardized checklists for all QC laboratories; ensure issues are captured, escalated, and closed.
• Conduct audit trail review for QC instruments and systems, ensuring timely and compliant documentation .
• Review and maintain QC laboratory logbooks for accuracy, completeness, and compliance with GDP requirements.
• Attend all Facilities & Controls (FAC) meetings; escalate QC‑related issues, equipment risks, and sample handling concerns.
• Investigate and document equipment Out‑of‑Tolerance (OOT) events and coordinate required follow-up actions.
• Perform cell culture activities and maintain aseptic technique to support cell‑based analytical assays as needed.
• Perform Rees alarm risk assessments for controlled‑temperature units (CTUs) and establish clear criteria for when deviations must be initiated (e.g., defined threshold durations for -80°C units).
• Conduct quarterly reviews of Rees alarms to identify trends, risks, and required corrective actions.
• Coordinate calibrations (Cals), preventative maintenance (PMs), and equipment maintenance (EMs) across QC laboratories; ensure timely completion and documentation.
• Update, revise, and create equipment-related SOPs, work instructions, alarm response procedures, and lifecycle documents.
• Support method qualification/validation, material qualification, and equipment qualification (IQ/OQ/PQ) activities as needed.
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• Author and revise SOPs, forms, and documentation related to sample management, lab operations, alarm response, and equipment handling.
• Participate in internal audits, external inspections, and quality system assessments by providing documentation and subject‑matter expertise.
• Collaborate cross‑functionally with QC, QA, Manufacturing, Supply Chain, and Facilities to improve processes, reduce risks, and strengthen compliance.
• Contribute to continuous improvement initiatives to streamline laboratory workflows and enhance data integrity.

About You:

• Bachelor’s degree in a scientific discipline (Biology, Chemistry, Biochemistry, or related field).
• Minimum 4–6 years of experience in a GMP analytical laboratory, QC environment, or sample management role.
• Strong understanding of cGMP requirements and regulatory expectations for biotechnology and pharmaceutical QC operations.
• Experience with LIMS, electronic inventory systems, or sample tracking databases.
• Familiarity with stability programs, cold‑chain management, and chain‑of‑custody workflows.
• Strong organizational skills with exceptional attention to detail and documentation accuracy.
• Excellent communication skills and ability to work cross‑functionally.
• Demonstrated problem‑solving ability and adaptability to shifting priorities.
• Proficiency with MS Office and laboratory equipment software.