The Associate Director, Quality will be responsible for driving technical excellence and regulatory compliance at ATLab Indianapolis, a next-generation commercial-scale facility for sterile radiopharmaceutical manufacturing. This position plays a critical cross-functional role in ensuring the facility operates with maximum reliability, safety, and regulatory readiness, contributing directly to the timely and compliant delivery of life-saving therapies.

The Associate Director, Quality supports the company’s short- and long- term goals for maintaining Quality Systems and Compliance. This position provides direct oversight for the evaluation, implementation, execution and follow-up on quality systems in support of GMP compliance and release of finished product. This role oversees quality assurance of the manufacturing and packaging processes and procedures, the final review of investigations, and appropriate implementation of corrective actions to prevent recurrence.

This role also provides input into the overall decision-making process pertaining to quality problems, internal and external, that can have far reaching results in terms of rejected batches, stock withdrawals, quarantined goods, revised production and marketing schedules and added manufacturing costs.

Job Duties:

• Provides daily oversight of the QA teams responsible for supporting all production/processing areas.
• Develops and monitors appropriate KPI's for batch documentation review, Right First Time (RFT) and support of timely batch release.
• Responsible for department resource planning, talent development, and budget administration with regards to QA personnel.
• Directs investigations of product complaints and manufacturing discrepancies for manufactured products and ensures completion of appropriate documentation.
• Performs review of root-cause analysis and other problem-solving activities to identify effective corrective and preventative actions and appropriate effectiveness measures.
• Provides QA review and approval of Investigations, CAPAs, SOPs, Change Controls, and protocols/reports.
• Ensures completeness, accuracy and compliance of all documentation. Coordinates the preparation, review, and approval of the Annual Product Quality Reports and any established metrics / KPIs.
• Participates in Regulatory/FDA inspections and audits by providing information or expediting/obtaining information required by the inspectors/auditors.
• Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required.