Director, QA for QC

How You Will Achieve More:

The Director, QA for QC is responsible for providing strategic and operational quality oversight of Quality Control activities supporting the development, manufacture, testing, release, and lifecycle management of gene editing products. This role provides technical leadership and scientific decision-making for analytical control strategies, method performance, reference standards, specifications, and laboratory investigations, and serves as a recognized technical authority for QC-related matters across the product lifecycle with particular emphasis on building the analytical rigor, data-driven predictability, and organizational maturity required to support successful transition from clinical to commercial manufacturing. A critical focus of this role is establishing and maturing trending and predictive quality capabilities using stability, routine release, and in-process testing data and supporting the maturity of a QC oversight function appropriately scaled for commercial supply. The Director will also serve as a mentor and technical coach to personnel in QA for QC department.

The Director ensures QC activities are executed in compliance with global GMP regulations and internal Quality Systems, and serves as the primary Quality authority for QC compliance, analytical control strategy, investigation oversight, stability programs, reference standards, and test method governance. This role partners closely with Analytical Development to ensure effective method design, lifecycle transfer, performance characterization, and alignment of analytical control strategies from early development through commercialization, and partners with QA GMP Operations, Global Technical Operations, Process Development, Regulatory Affairs, and external testing laboratories/CMOs.

Responsibilities:

• Provide quality and technical oversight and governance for all QC activities, including Drug substance/Drug Products release, stability, and specialized testing for gene editing therapies.
• Ensure outsourced testing operations operate in compliance with applicable global regulations (FDA, EMA, ICH) and internal Quality standards appropriate to novel modality products.
• Act as the primary Quality escalation point for critical QC-related quality and compliance issues, applying sound risk-based judgment given the evolving regulatory landscape for gene editing therapeutics.
• Establish and lead a robust, data-driven trending program leveraging stability, release, and routine testing data to proactively identify shifts in analytical, process, or product performance enabling predictive quality management.
• Partner with Analytical Development, Process Development, and Manufacturing Sciences to build statistically sound approaches to specification setting, control limits, and continued process verification (CPV) that support commercial-scale manufacturing.
• Champion the use of statistical tools, control charting, and multivariate trend analysis to support early detection of variability and to inform proactive risk mitigation ahead of formal investigations.
• Ensure trend outputs are meaningfully integrated into QRM pathways.
• Provide quality oversight and approval of External Laboratory Investigations (OOS, OOT, atypical results, deviations, data integrity events), ensuring investigations are scientifically sound, risk-based, appropriately escalated, trended for systemic issues, and supported by effective CAPAs through closure.
• Support lifecycle management for referen