CDC Global Solutions
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
#J-18808-Ljbffr
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
#J-18808-Ljbffr