Senior Director of Operations

Senior Director of Operations - Texas - Semi solids CDMO

CDC is partnering with a US based CDMO operating 4 sites across NA, specialising in drug product and API manufacturing. The company has recently made significant investments in its semi-solids facility, expanding capacity and commissioning 2 new production lines. We’re now seeking a strong leader to help drive the team and ensure continued success.

This position is responsible for driving operational excellence, optimising resource utilisation, fostering a culture of continuous improvement, and maintaining strict compliance with cGMP regulations. The Senior Director oversees manufacturing, packaging, maintenance, and shipping/receiving, ensuring customer delivery commitments are met while maximizing efficiency, quality, and safety.

Responsibilities:

• Lead and manage operations teams of 10–200+ employees, driving cost savings, problem-solving, and on-time delivery.
• Ensure full compliance with FDA, DEA, cGMP, OSHA, and CFR requirements; lead audit readiness and regulatory risk mitigation
• Provide strategic leadership across all operational functions, aligned with company objectives and growth plans.
• Own operational budgets (manufacturing, packaging, maintenance, logistics), financial analysis, and cost optimization.
• Deliver customer commitments through effective planning, execution, and capacity management
• Establish and drive KPIs, continuous improvement initiatives, and Lean-based performance enhancements
• Optimize workflows, facility layouts, product flow, and storage using best practices
• Develop and maintain capacity models for equipment, people, and facilities to support current and future demand
• Develop and maintain capacity models for equipment, people, and facilities to support current and future demand
• Ensure robust SOPs and quality systems in partnership with Quality Assurance
• Lead training programs, competency development, and a strong quality-first culture
• Drive process, equipment, and technology improvements, including ROI-based capital investments
• Lead continuous improvement, innovation, and operational excellence initiatives
• Coach, mentor, and develop leaders; manage succession planning and talent development
• Oversee hiring, performance management, and employee relations across operations
• Foster strong cross-functional collaboration to resolve bottlenecks and improve outcomes
• Manage vendor relationships and contracts to maximize value and service levels
• Lead safety programs, incident investigations, and CAPA implementation
• Serve as operational lead for new product introductions, CapEx projects, facility expansions, and commercialization efforts
• Act as a key operational partner to QA, senior leadership, clients, and regulatory bodies
• Perform additional strategic initiatives as assigned by EVP, Rx Operations
• Champion a quality-focused culture within operations, ensuring quality is integrated into all processes and practices, and that quality commitments are consistently met.

Requirements:

• Bachelor’s degree required; Master’s in scientific or operational discipline preferred
• 15+ years’ experience in FDA cGMP environments, ideally pharma solid dose, semi-solid, and liquid manufacturing (including commercial products)
• 10+ years’ manufacturing leadership with progressive operational responsibility
• Extensive experience leading FDA, DEA, and regulatory audits
• Proven ability to lead large teams (10–200 employees) and consistently meet operational targets
• Strong Lean manufacturing and continuous improvement track record
• Deep knowledge of pharma manufacturing processes, equipment, and cGMP/FDA/DEA requirements
• Exceptional people leadership, coaching, and team-building skills
• Strong cross-functional communication and collaboration skills

If you are interested in this role then apply directly or reach out to harriet@cdcglobal.co.uk