Note: The job is a remote job and is open to candidates in USA. K3-Innovations, Inc. is seeking an experienced Associate Director, Quality Capital Programs to support the development of a new state-of-the-art sterile manufacturing campus for a leading global biopharmaceutical organization. This role involves providing strategic quality leadership and ensuring compliance with regulatory standards throughout the design and operational readiness of the facility.

Responsibilities

• Provide strategic quality leadership for capital expansion projects supporting a new sterile manufacturing facility
• Ensure facility design and manufacturing processes comply with GMP regulations and global pharmaceutical quality standards
• Support contamination control strategies for aseptic manufacturing operations
• Partner with Engineering, Operations, Validation, Technical Operations, and Quality teams throughout facility design and implementation
• Provide expertise in QC Microbiology and aseptic processing to support manufacturing readiness
• Assess project risks and develop mitigation strategies to ensure regulatory compliance
• Lead cross-functional quality initiatives supporting capital programs and site readiness
• Ensure quality systems, documentation, and operational processes align with regulatory expectations
• Drive continuous improvement initiatives while supporting multiple complex programs simultaneously
• Serve as a strategic quality advisor throughout the lifecycle of capital projects

Skills

• Bachelor's or Master's degree in Microbiology, Engineering, Life Sciences, or a related scientific discipline
• Minimum 10 years of pharmaceutical industry experience
• Extensive knowledge of: Aseptic Manufacturing, QC Microbiology, Contamination Control Strategies, GMP Facility Design, Pharmaceutical Manufacturing Operations
• Strong understanding of FDA, EMA, and global pharmaceutical regulatory requirements
• Demonstrated experience supporting sterile manufacturing or biologics facilities
• Proven ability to lead multiple strategic initiatives in a complex, matrixed organization
• Excellent organizational, communication, and leadership skills
• Strong quality mindset with experience in Quality Assurance, Engineering, Manufacturing, Technical Operations, or related pharmaceutical disciplines
• Experience supporting greenfield pharmaceutical manufacturing facilities or major capital expansion projects
• Knowledge of contamination control strategies for sterile manufacturing environments
• Experience working within biologics or sterile injectable manufacturing operations
• Demonstrated success leading cross-functional teams through large-scale capital projects
• Experience supporting regulatory inspections and quality compliance initiatives

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