Sr. Manager​/AD, Quality Assurance

Associate Director / Director, Quality Assurance

Position Summary

The Associate Director / Director, Quality Assurance is a hands‑on quality leader responsible for overseeing daily QA while helping strengthen the quality systems, operating discipline, and cross‑functional execution needed to support our growth as a contract manufacturing organization. This role is expected to operate above a pure manager level: the individual must be able to oversee core quality activities, partner effectively across functions, support audits and inspections, and help shape practical, scalable quality systems.

At the same time, this person must stay close to the work by spending regular time in labs and manufacturing to understand how operations run and to ensure quality solutions are feasible for the business.

• Provide direct oversight of daily QA operations, including product and material release, deviations, investigations, CAPAs, complaints, change control, internal audits, and inspection readiness activities.
• Ensure quality operations are calibrated correctly across our dual clinical and commercial scope.
• Manage material and supplier quality activities, including vendor qualification, incoming material review, and supplier change notifications, ensuring supply chain inputs do not introduce uncontrolled compliance risk into manufacturing operations.
• Represent Quality in client program reviews, project management meetings, and executive discussions.

• Own the design, implementation, maintenance, and continuous improvement of our core quality management systems, including document control, change control, deviation and investigation management, CAPA, training, internal audit, and stability program administration.
• Ensure quality systems are not only compliant but genuinely usable for front‑line manufacturing and QC teams.
• Evaluate and implement eQMS and LIMS platforms and upgrades; serve as the quality systems owner for validation, rollout, training, and ongoing administration of electronic quality and laboratory data management systems.
• Establish and maintain quality metrics and leading indicators that give site leadership an accurate, real‑time view of operational compliance health.

• Lead and own the site’s deviation and investigation program: ensure deviations are captured completely and promptly, investigations are conducted with appropriate depth and technical rigor, and root cause conclusions are supported by evidence.
• Drive OOS/OOT investigations from QA oversight perspective: ensure QC’s laboratory investigation is methodologically sound and Phase I conclusions are technically defensible before proceeding to Phase II.

• Serve as the primary quality representative and front‑room lead for all regulatory and client audits and inspections, including FDA, EU, and other applicable regulatory bodies, as well as sponsor quality audits across clinical and commercial programs.
• Develop and maintain sufficient operational subject‑matter expertise across key site functions — including Manufacturing, Facilities, Utilities, Validation, QC, and Supply Chain.
• Lead pre‑inspection preparation activities, including mock audits, back‑room logistics, document retrieval readiness, and SME preparation.
• Lead all audit and inspection follow‑up independently: draft audit responses that are technically accurate, operationally realistic, and demonstrate a genuine understanding of root cause rather than administrative acknowledgment; drive CAPAs to timely, substantive closure; and ensure all commitments made to regulatory agencies or clients are tracked, owned, and fulfilled.
• Conduct and oversee a robust internal audit program that proactively identifies compliance gaps, system failures, and execution drift before external parties do; translate internal audit findings into prioritized remediation with clear ownership, timelines, and effectiveness verification.

• Monitor evolving regulatory guidance from FDA, EMA, ICH, and other relevant bodies; translate new guidance into practical…