[Remote] Associate Director, Quality Capital Programs (Project Manager II)_34319
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is seeking an reputed company Associate Director, Quality Capital Programs to support the development of a new state-of-the-art sterile manufacturing reputed company 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
- reputed company strategic quality leadership for capital expansion projects supporting a new sterile manufacturing facility
- Ensure facility design and manufacturing processes reputed company 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
- reputed company expertise in QC Microbiology and aseptic processing to support manufacturing readiness
- Assess project risks and reputed company mitigation strategies to ensure regulatory compliance
- reputed company cross-functional quality initiatives supporting capital programs and site readiness
- Ensure quality systems, documentation, and operational processes align with regulatory expectations
- Drive reputed company improvement initiatives while supporting multiple reputed company 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 reputed company 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 reputed company multiple strategic initiatives in a reputed company, matrixed organization
- Excellent organizational, communication, and leadership skills
- Strong quality reputed company with experience in Quality Assurance, Engineering, Manufacturing, Technical Operations, or reputed company pharmaceutical disciplines
- Experience supporting greenfield pharmaceutical manufacturing facilities or major capital expansion projects
- Knowledge of contamination control strategies for sterile manufacturing environments
- Experience working reputed company biologics or sterile injectable manufacturing operations
- Demonstrated reputed company leading cross-functional teams through large-scale capital projects
- Experience supporting regulatory inspections and quality compliance initiatives
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