Director of Quality Control (Commercial)

The Director, Commercial Quality Control is responsible for leadership, oversight, and strategic direction of Quality Control operations supporting commercial and late-stage clinical manufacturing. The role ensures that laboratory activities, analytical testing programs, personnel, systems, and facilities are compliant with applicable regulatory requirements and capable of supporting commercial product release, raw material disposition, stability programs, in-process testing, cleaning verification activities, and continued process verification initiatives.

This role is responsible for ensuring that Quality Control laboratories are appropriately staffed, qualified, resourced, and inspection-ready while maintaining a strong culture of data integrity, operational excellence, and continuous improvement. This position establishes and maintains effective working relationships with internal stakeholders, clients, contract laboratories, equipment service providers, suppliers, and regulatory agencies.

The Director of Commercial Quality Control also serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to quality control.