Provide QA leadership and independent oversight of QC activities for drug substance/product and release testing. Ensure cGMP compliance, data integrity, method lifecycle management, investigations, change control, CAPAs, and inspection readiness while partnering with QC and cross-functional teams.
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 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 Agencies
All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered property of Adverum. Agencies must be expressly engaged by Adverum’s Talent Acquisition team 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.
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.
What You'll Do:
- 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
About You:
- 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
Adverum Biotechnologies Redwood, California, USA Office
100 Cardinal Way, Redwood, CA, United States, 94063
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