Director, Quality

Select how often (in days) to receive an alert:

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world-from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe.

We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Leads the Global Aseptic Center of Excellence (ACE) and serves as the accountable enterprise leader for aseptic processing, sterility assurance, and microbiology governance across Bausch + Lomb sterile pharmaceutical and sterile medical device manufacturing operations, as applicable to product and site. Provides enterprise leadership, technical authority, governance, and strategic direction; establishes consistent, science-based, and risk-based standards; and harmonizes systems, technologies, metrics, and practices across the network.

The role strengthens contamination control, inspection readiness, regulatory confidence, proactive risk management, and reliable sterile-product supply through one recognizable Bausch + Lomb aseptic and sterility assurance system.

• Establish and maintain the enterprise CCS framework and global standards aligned with applicable FDA requirements, EU GMP Annex 1, USP standards, ISO standards, and other relevant health authority expectations.
• Review and approve site CCSs, material revisions, and time-bound waivers from global aseptic and sterility assurance standards.
• Harmonize environmental and personnel monitoring systems, sampling strategies, escalation frameworks, trending methodologies, and alert/action levels.
• Standardize microbiology laboratory equipment, testing strategies, methods, data management, organism identification, objectionable organism assessment, and responses to excursions and out-of-specification or out-of-trend events.
• Harmonize disinfection and sanitization programs, gowning qualification, aseptic observer programs, sterile filtration, endotoxin control, sterilization, container closure integrity, and aseptic process simulation/media fill programs.
• Provide technical authority for barrier and facility design, critical utilities, process validation, isolators/RABS, sterilization and bio-decontamination cycles, and environmental-monitoring design.
• Design and implement global education, training, qualification, coaching, and community-of-practice programs.

• Drive adoption of rapid microbiological methods, automated monitoring, barrier technology, automation, intervention reduction, and digital data systems.
• Establish a repeatable deployment model to evaluate emerging technologies, build business cases, pilot solutions, and deploy qualified solutions across the network.
• Partner with sites on new facilities, expansions, upgrades, and capital projects to ensure robust sterility assurance design and implementation of global standards.
• Participate in appropriate industry forums and integrate relevant regulatory,…