Global Aseptic Quality & Sterility Leader

Bausch + Lomb; Tampa (FL); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Bausch + Lomb in the United States seeks an experienced leader to head the Global ACE program, overseeing aseptic processing, sterility assurance, and microbiology governance across manufacturing operations. You will set standards, drive risk-based decisions, and ensure regulatory readiness.

Lead enterprise-wide strategies, collaborate with site leaders, and deliver KPI-driven improvements to contamination control, qualification, and process validation in a fast-paced, global network.

Qualifications

• Bachelor's degree in Microbiology, Biology, Engineering, Pharmacy, or a related scientific discipline required; advanced degree preferred.
• Minimum 15 years of progressive experience in microbiology, contamination control, aseptic processing, sterilization, and sterility assurance with leadership experience.
• Deep technical expertise in microbiology, aseptic processing, environmental monitoring, contamination control, investigations, and validation.
• Extensive knowledge of FDA, EU GMP Annex 1, USP, ISO standards and relevant regulations.
• Experience supporting domestic/international health authority inspections as SME in microbiology/aseptic/sterility.
• Ability to influence across a global matrix, align sites/functions, and lead during significant quality events.

Responsabilités

• Establish and maintain the enterprise CCS framework and global standards aligned with FDA, EU GMP Annex 1, USP and ISO standards.
• Review and approve site CCSs, material revisions, and waivers from global standards.
• Harmonize environmental and personnel monitoring systems, sampling strategies, and escalation frameworks.
• Standardize microbiology lab equipment, testing methods, data management, and excursions handling.
• Harmonize disinfection, gowning qualification, sterile filtration, endotoxin control, and sterilization.
• Provide technical authority for barrier design, utilities, process validation, isolators, and environmental-monitoring design.
• Design and implement global education, training, and community-of-practice programs.
• Lead governance and escalation: run ACE meetings and respond to contamination events.

Connaissances

Leadership

Regulatory knowledge

Cross-functional collaboration

Strategic planning

Formation

Bachelor's degree in Microbiology, Biology, Engineering, Pharmacy, or related

Description du poste

Bausch + Lomb in the United States seeks an experienced leader to head the Global ACE program, overseeing aseptic processing, sterility assurance, and microbiology governance across manufacturing operations. You will set standards, drive risk-based decisions, and ensure regulatory readiness.

Lead enterprise-wide strategies, collaborate with site leaders, and deliver KPI-driven improvements to contamination control, qualification, and process validation in a fast-paced, global network.