We are seeking an accomplished Quality Assurance Head with extensive experience in sterile injectable pharmaceutical manufacturing to lead all Quality functions for our FDA-regulated manufacturing operations. This role is responsible for establishing and maintaining a world-class Quality organization that ensures compliance, drives operational excellence, and supports business growth.
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Develop and execute the company's quality strategy in support of business objectives.
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Serve as the executive leader responsible for all Quality functions across the organization.
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Build a high-performance quality culture focused on compliance, operational excellence, and continuous improvement.
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Advise executive leadership on quality risks, regulatory strategy, and compliance initiatives.
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Lead the Quality Management System, including deviations, investigations, CAPAs, change controls, complaints, recalls, document management, training, supplier quality, and management review.
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Ensure the organization maintains a constant state of FDA inspection readiness.
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Drive quality metrics and continuous improvement initiatives across the business.
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Provide quality oversight of all sterile manufacturing operations, including:
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Aseptic processing
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Environmental monitoring
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Media fills
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Sterility assurance
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Contamination control strategy
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Personnel qualification
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Facility and utility monitoring
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Ensure all operations meet FDA expectations for sterile drug manufacturing.
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Provide final approval for batch disposition and commercial product release.
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Review and approve investigations, deviations, validation protocols, reports, and quality risk assessments.
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Ensure timely resolution of quality events while maintaining product quality and patient safety.
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Direct QC laboratories responsible for chemical, microbiological, and stability testing.
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Oversee OOS, OOT, and laboratory investigations.
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Ensure laboratory compliance with GMP and data integrity requirements.
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Provide Quality oversight for qualification and validation activities, including:
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Process Validation
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Cleaning Validation
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Equipment Qualification (IQ/OQ/PQ)
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Computer System Validation
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HVAC Systems
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Water for Injection (WFI)
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Clean Steam
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Compressed Gases
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Lead FDA, customer, and international regulatory inspections.
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Prepare executive responses to FDA observations and Warning Letters when applicable.
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Monitor evolving global regulations and implement proactive compliance strategies.
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Partner with Manufacturing, Engineering, Regulatory Affairs, Technical Services, Supply Chain, and Operations to support product launches, technology transfers, and process improvements.
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Act as the Quality representative on executive leadership initiatives.
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Recruit, mentor, and develop Quality leaders.
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Build organizational capability through succession planning and professional development.
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Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, or a related scientific discipline.
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Advanced degree preferred.
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10+ years of progressive pharmaceutical manufacturing experience.
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10+ years of Quality leadership within sterile injectable manufacturing.
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Extensive experience leading Quality organizations in FDA-regulated sterile injectable facilities is required.
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Strong working knowledge of aseptic processing, contamination control, sterility assurance, and Annex 1 principles.
