What are the responsibilities and job description for the Director, Quality Operations position at EPM Scientific?
Director, Quality Operations
Location: Kansas City, MO (relocation assistance offered)
Position Overview:
This is a senior quality leadership role within a fast‑paced, customer‑focused organization. The position is responsible for leading site Quality Assurance while contributing to broader business unit quality strategy and ensuring consistent execution of quality systems, compliance, and performance. The role operates as a core member of the site leadership team and focuses on driving continuous improvement, regulatory readiness, and strong operational outcomes.
Key Responsibilities:
- Contribute to business unit quality strategy, including development of global policies, procedures, and cross-site alignment
- Serve on the site leadership team, partnering with the General Manager to drive a culture of safety, quality, compliance, and continuous improvement
- Lead the site Quality Assurance function, including team leadership, performance management, development, and succession planning
- Oversee investigations related to deviations, trends, and customer complaints, ensuring timely resolution and effective CAPAs
- Review and approve GMP documentation, including SOPs, batch records, and validation protocols/reports
- Ensure data integrity, procedural alignment, and implementation of global quality standards at the site
- Oversee release activities, environmental monitoring, label control, and in-process quality operations (inspections, sampling, line clearance)
- Lead internal and external audit activities, including regulatory and customer inspections, responses, and follow-up actions
- Maintain clear communication and escalation of quality issues to site and senior leadership
- Oversee key quality systems including training, supplier quality management, and change control
- Drive continuous improvement initiatives with a focus on deviation reduction and operational performance
- Manage departmental budget, resources, and relationships with internal stakeholders and external clients
Requirements:
- Bachelor's degree in a scientific, engineering, or related discipline
- 10 years of experience in a regulated industry (pharmaceutical, chemical, or similar)
- 5 years of experience in quality or regulatory roles with increasing responsibility
- Prior experience leading teams and developing personnel
- Hands-on experience with validation across processes, equipment, systems, and methods
- Solid understanding of manufacturing, materials management, sourcing, and quality control