More jobs:
Director Operations- Accellix
Job in
Lombard, DuPage County, Illinois, 60148, USA
Listed on 2026-08-03
Listing for:
BioFire Diagnostics
Full Time
position Listed on 2026-08-03
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist -
Manufacturing / Production
Regulatory Compliance Specialist
Job Description & How to Apply Below
The Director, Operations – Accellix is responsible for leading end-to-end manufacturing operations across multiple sites supporting the Accellix product line. This role oversees consumables and instrument manufacturing, ensuring alignment across locations to achieve business objectives related to safety, quality, delivery, cost, and operational excellence. The Director partners with cross-functional teams to drive performance, scalability, compliance, and continuous improvement in a GMP-regulated environment.
Key Responsibilities Operational Leadership- Lead manufacturing operations across multiple production sites to achieve throughput, quality, and delivery objectives.
- Establish and maintain consistent operational standards, processes, and performance expectations.
- Drive operational excellence through performance management, strategic planning, and continuous improvement initiatives.
- Ensure alignment of production schedules, priorities, and resources to support business goals.
- Lead and develop production leadership teams across multiple locations.
- Provide coaching, performance management, succession planning, and organizational development.
- Ensure appropriate staffing, capability development, and operational coverage to support business needs.
- Promote a culture of accountability, collaboration, safety, and employee engagement.
- Ensure manufacturing activities comply with GMP, GDP, quality system requirements, and company standards.
- Support audit readiness, deviation investigations, corrective and preventive actions (CAPA), and regulatory compliance activities.
- Maintain focus on product quality, traceability, documentation accuracy, and operational discipline.
- Reinforce quality standards that support product reliability and customer satisfaction.
- Monitor and drive key operational performance indicators.
- Identify performance gaps and implement corrective actions to improve results.
- Ensure visibility and reporting of operational performance across manufacturing locations.
- Support budget management, cost control, waste reduction, and operational efficiency initiatives.
- Partner with Quality, Supply Chain, Engineering, and Global Operations teams to ensure business execution.
- Support new product introductions, process improvements, validation activities, and operational readiness initiatives.
- Drive coordinated decision-making across functions to support customer and business requirements.
- Resolve issues affecting product quality, functionality, supply, or delivery.
- Bachelor's degree in Engineering, Life Sciences, Operations Management, Supply Chain, Manufacturing, or a related field.
- 8+ years of experience in manufacturing, operations, or production environments.
- 3+ years of people leadership and team management experience.
- Experience operating within a GMP-regulated industry such as biotechnology, diagnostics, pharmaceuticals, or medical devices.
- Experience with reagent manufacturing, biomolecule production, drying or stabilization processes, microfluidics, or consumable manufacturing.
- Experience managing operations across multiple sites or geographically dispersed teams.
- Strong manufacturing and operational leadership capabilities.
- Proven ability to lead teams, develop talent, and drive organizational performance.
- Experience using metrics and KPIs to drive business results.
- Strong problem-solving, decision-making, and conflict-resolution skills.
- Ability to lead cross-functional initiatives and influence stakeholders.
- Knowledge of GMP, GDP, quality systems, and regulatory requirements.
- Excellent communication, collaboration, and continuous improvement skills.
- Proficiency with Microsoft Office applications, including Outlook, Teams, Word, and Excel.
- Combination of office and manufacturing environments.
- Ability to work on the production floor and wear required PPE.
- Ability to sit, stand, walk, and move throughout manufacturing facilities.
- Occasional domestic and international travel may be required.
The estimated salary range for this role based in Illinois…
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