Associate Director, Quality Operations

Bachelor's degree required preference in a Life Science field; advanced degree preferred.

Minimum 8 years’ experience in Quality or pharmaceutical industry experience.

Minimum 5 years’ experience in a management role.

Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Must be able to qualify for entry into Class A/B aseptic facilities.

The Associate Director Quality Operations is accountable for end-to-end Quality Operations and quality oversight for the Focus Factory.

This role is a member of the Site Quality Leadership Team and a key member of the Focus Factory Leadership Team, reporting directly to the Quality Director.

The incumbent owns quality performance for the Focus Factory and ensures that operations are executed in compliance with cGMP requirements, site procedures, corporate quality policies, applicable regulatory expectations, and client commitments.

The role provides strategic and day-to-day leadership across Filling Quality Line Operations, Finishing /Inspection/Labeling/Packaging Quality Operations, Environmental Monitoring sampling/support, Warehouse and shipping quality oversight as applicable, Batch Record Review, Batch Disposition/Release, deviation/nonconformance management, and CAPA.

The role ensures quality decisions are made with appropriate scientific, compliance, patient safety, and business risk considerations, while driving a culture of ownership, proactive escalation, continuous improvement, and right-first-time execution.

Establish clear quality priorities, resource plans, and coverage models to support 24/7 operations, including manufacturing floor support, real-time quality decision-making, and timely escalation of quality risks.