Associate Director, Quality Operations

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.

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.

• •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.

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• •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.