Associate Director, Quality Operations

Simtrabps; Bloomington (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking an Associate Director of Quality Operations. The role oversees end-to-end quality for the Focus Factory and reports to the Quality Director, ensuring cGMP compliance, adherence to site procedures, and client commitments across filling, finishing, labeling, packaging, and testing.

The position requires strategic and hands-on leadership to maintain quality, regulatory readiness, and continuous improvement.

Responsibilities

• End-to-end Quality Operations oversight for the Focus Factory.
• Ensure operations comply with cGMP, procedures, and client commitments.
• Provide strategic and day-to-day leadership across Filling, Finishing, Inspection, Labeling, Packaging, and related QC activities.
• Lead CAPA, deviation, and batch disposition processes; support inspections.

Job description

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra?

Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.

Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.

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. 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.

Role/Decision Scope

Single point of Quality Operations accountability for the assigned Focus Factory, from manufacturing readiness through batch disposition and release.

Provides independent quality oversight and quality decision-making for routine operations, escalations, deviations, CAPA effectiveness, and inspection readiness.

Serves as an empowered Quality Leader and designee to the Quality Director for defined reviews, approvals, Quality Review Board endorsements, and escalation forums, as delegated by procedure or written delegation.

Partners with other cross Focus Factory quality functions, Manufacturing, Technical Services, Engineering, Supply Chain, QC, Regulatory, and Client Services to ensure quality, compliance, supply continuity, and patient safety are appropriately balanced and documented.

The 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