Associate Director, QA-QC Operations (Contract)

Adverum Biotechnologies, Inc.•Redwood City, CA

About The Position

Adverum Biotechnologies, Inc., a 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 physiciansâ 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. The Associate Director QA-QC Operations is responsible for providing Quality Assurance leadership and independent oversight of all Quality Control (QC) activities supporting drug substance, drug product, cell banks, and finished product release and stability. The individual must provide strategic leadership within internal and external CMC functions. This includes the ability to work independently and also as an effective and engaged cross-functional leader and team member in a fast-paced environment. Strong initiative and independent follow-through are essential for this role. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required. This role ensures that QC systems, documentation, data integrity practices, method lifecycle management, and release testing activities comply with cGMP requirements, regulatory expectations (FDA, EMA), and internal quality standards. The position acts as the primary QA business partner to QC and serves as the QA lead for all QC-related systems, processes, change controls, investigations, and method validation activities.

Requirements

13+ years of experience in QA and/or QC within biotechnology or pharmaceutical industry.
Strong, demonstrated experience with Analytical method validation, QC data review, OOS investigations, cGMP laboratory operations
Experience supporting Contract Manufacturing Organizations and Contract Testing Laboratories.
Strong technical understanding of analytical testing
Independent decision-making ability
Risk-based thinking
Inspection readiness mindset
Excellent written and verbal communication skills
Ability to lead without direct authority

Responsibilities

Provide independent QA review and approval of policies, procedures and QC-generated documents, including test methods, specifications, protocols and reports (validation, qualification, transfer), stability documentation, analytical comparability studies.
Perform QA data verification for release and stability testing ensuring technical review is completed by QC prior to QA compliance review.
Support and/or approve lot disposition decisions based on QC data package
Provide QA oversight of method validation, method verification, method transfer (internal and external CTLs), method finalization and implementation
Confirm alignment between approved specifications and validated methods.
Own QA oversight of QC-related systems, including change controls, deviations and OOS/OOT/OOE investigations, CAPAs and risk assessments.
Ensure timely and thorough investigations with appropriate root cause analysis.
Ensure appropriate impact assessments (quality, regulatory, product).
Partner with QC leadership to drive continuous improvement.
Ensure ALCOA+ principles are consistently applied within QC.
Support inspection readiness and participate in regulatory inspections and audits as necessary.
Partner closely with QC, Regulatory Affairs, External Manufacturing, Process Development, Supply Chain