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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