Associate Director, Quality Operations

About the role

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.

Responsibilities

• 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.
• Provide guidance, support, direction, and leadership through positive interactions with all personnel during daily operations.
• Ensure the Focus Factory quality organization operates with strong ownership, accountability, and alignment to site quality strategy, operational goals, client commitments, and regulatory expectations.
• Develops department annual budget and ensures spending within expected quarterly forecasts.
• Assess workload, staffing, and skill mix to ensure the Quality Operations organization can provide effective oversight across all shifts and operating areas.
• Participate in escalated client issue resolution (conference calls, client visits, audits).
• Represent Quality Operations during client audits and regulatory inspections as needed. Provide information as necessary to auditors that establishes credibility and demonstrates compliance with cGMPs.

Quality Oversight, Compliance, and Batch Disposition

• Ensure quality oversight of aseptic filling operations, inspection, labeling and packaging operations, warehouse operations, finished product reserve sample inspection, finished product sampling, and product shipment activities as applicable.
• Ensure timely and thorough QA review of batch records and associated documentation to meet internal release targets and contractual batch release commitments.
• Verify that each batch disposition decision is scientifically justified, fully documented, compliant with procedures and regulations, and appropriately considers patient safety, product quality, SISPQ, and client/regulatory commitments.
• Provide direction for review, approval, and escalation of deviations, nonconformance reports, investigations, root cause analyses, CAPAs, and effectiveness checks related to Focus Factory operations.
• Identify, assess, and escalate emerging quality and compliance risks, including recurring deviations, quality system weaknesses, aseptic processing risks, sterility assurance risks, and trends that may affect batch disposition or supply.

Focus Factory Performance and Quality KPIs

• Own Focus Factory quality and compliance performance metrics, including right-first-time performance, deviation aging, CAPA timeliness/effectiveness, batch release cycle time, inspection readiness, training compliance, and other site-defined KPIs.
• Develop and use quality data, dashboards, and trend reports to drive performance management, proactive risk reduction, and decision-making at Focus Factory and Site Quality Leadership forums.
• Lead or sponsor continuous improvement projects that strengthen quality culture, reduce repeat deviations, simplify execution, improve documentation quality, and support reliable batch release and supply performance.
• Ensure robust management review and escalation of quality issues, including appropriate use of Quality Review Board and other governance forums.

People Leadership, Capability Building, and Culture

• Interview, hire, coach, develop, and retain a high-performing Quality Operations team; set clear expectations, performance objectives, development plans, succession plans, and accountability measures.
• Create an environment of teamwork, inclusion, transparency, and constructive challenge where quality decisions are made with integrity and where safety, identity, strength, purity, and quality are reflected in the finished product.
• Ensure training compliance and capability development for the QA team, including cGMP expectations, aseptic/sterility assurance concepts, deviation investigation, CAPA, batch record review, data integrity, and decision-making standards.
• Model expected leadership behaviors, including prioritization, delegation, strategic thinking, cross-functional collaboration, proactive escalation, and continuous improvement.