Director, Quality Operations

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
• Lead 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