Director, Quality Assurance (Site Quality Head)

Site Quality Leadership & Strategy

• Represent QA in cross-functional team meetings and interact with Manufacturing, Process Sciences, Facilities & Engineering, Supply Chain, Analytical Sciences, Regulatory, etc.
• Maintain updated and relevant knowledge of the GMP landscape, regulations, and guidelines.
• Drive risk-based quality decision-making, and lead escalation and resolution of critical quality events that may impact product supply, data integrity, or patient safety.
• Author, review, and provide technical QA support for site-related sections of regulatory filings and agency interactions.
• Support any site or regulatory body inspections.
• Manage QA team activities to support internal operations, supply chain, quality control, and facilities.
• Lead, mentor, and build a high-performing local Quality Assurance team.
• Trend and report key quality metrics to the leadership team.

Quality Operations and Product Disposition

• Provide quality leadership and operational oversight for environmental monitoring, clinical manufacturing (AAV/Gene Therapy), analytical testing, stability, batch record review, and disposition.
• Provide guidance and recommendations to ensure material is manufactured in accordance with established procedures, CGMPs, and appropriate regulations.
• Lead QA oversight for analytical method data review, method validation QA approvals, tech transfer protocol/report reviews, and product specifications.
• Author and revise QA related standard operating procedures and provide guidance for generation, review, and approval of process, equipment, test method, and other SOPs.
• Review and approve all GMP related documentation including internal protocols, reports, test records, batch records, labels, specifications and other documents for drug substance.
• Provide oversight and support staff to ensure executed batch records and associated documents are in compliance with approved procedures and CGMP expectations to determine acceptability of product disposition.
• Review and approve change controls related to the implementation or revision of process, method, and/or equipment changes.
• Provide quality oversight of root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
• Support and lead risk assessments to proactively identify, assess, and mitigate site risks.
• Support and maintain the site Contamination Control Strategy (CCS) to mitigate cross-contamination and environmental risks.

Material and Supply Chain Quality

• Provide quality leadership and operational oversight for raw materials and reagent release, specifications, incoming controls, and storage.
• Lead teams to resolve any non-conforming materials and site supply chain risks.

Facility and Validation Oversight

• Direct Quality oversight for commissioning, qualification, and validation (CQV) of site facilities, process equipment, automated systems, and analytical instrumentation.
• Oversee site computer system validation (CSV) and data integrity initiatives to comply with 21 CFR Part 11 and global guidelines.
• Provide Quality oversight for facilities, utilities, equipment, and instrument maintenance and management.
• Prioritize projects appropriately and with flexibility to accommodate changing program objectives.
• Identify opportunities for improvement and drive continuous improvement initiatives.
• Perform other duties and projects as assigned by management.