Director, Quality

Bausch + Lomb • US-FL-Tampa, FL

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About The Position

The Director, Quality leads the Global Aseptic Center of Excellence (ACE) and serves as the accountable enterprise leader for aseptic processing, sterility assurance, and microbiology governance across applicable Bausch + Lomb sterile pharmaceutical and sterile medical device manufacturing operations. The role provides technical authority, governance, and strategic direction while establishing consistent, science-based, risk-based standards and harmonizing systems, technologies, metrics, and practices across the network. Its purpose is to strengthen contamination control, inspection readiness, regulatory confidence, proactive risk management, and reliable sterile-product supply through a unified Bausch + Lomb aseptic and sterility assurance system.

The role establishes and maintains the enterprise Contamination Control Strategy (CCS) framework and global standards; reviews site CCSs and material revisions; harmonizes monitoring, laboratory, disinfection, gowning, sterilization, filtration, and process simulation programs; and provides technical authority for facility and barrier design, critical utilities, and validation. It also leads global training and qualification programs, advances technology adoption, supports capital projects, develops enterprise performance measures, and leads governance and technical responses to significant quality events. The position exercises authority through the ACE operating model and defined decision rights, in partnership with accountable site and functional leaders.

The role does not replace accountable functional ownership: Site Quality retains batch disposition and release; Operations retains production, staffing, and scheduling; Quality Control retains routine testing and laboratory execution; Engineering retains capital delivery; and Regulatory Affairs retains ownership of submissions.

Requirements

• Bachelor's degree in Microbiology, Biology, Engineering, Pharmacy, or a related scientific discipline.
• Minimum 15 years of progressive experience in microbiology, contamination control, aseptic processing, sterilization, and sterility assurance within sterile pharmaceutical and/or sterile medical device manufacturing, with significant leadership experience.
• Deep technical expertise in microbiology, aseptic processing, environmental monitoring, contamination control, investigations, and validation.
• Extensive knowledge of applicable regulations and standards, including FDA requirements, EU GMP Annex 1, USP standards, and relevant ISO standards.
• Demonstrated experience supporting domestic and international health authority or notified body inspections as a microbiology, aseptic processing, or sterility assurance subject matter expert.
• Demonstrated ability to influence across a global matrix, align diverse sites and functions, make risk-based decisions, communicate with executives, and lead during significant quality events.
• Must be authorized to work for any employer in the United States; the company is unable to sponsor or take over sponsorship of an employment visa.

Nice To Haves

• Advanced degree.

Responsibilities

• 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, scientific, and technical learning into network standards and practices.
• Establish common global KPIs, leading indicators, scorecards, and performance expectations, including contamination recovery and alert rates, repeat excursion patterns, laboratory investigations, nonconformances, right-first-time performance, and investigation timeliness.
• Use enterprise trending and benchmarking to detect drift, identify emerging risk, reduce recurring nonconformance drivers, and enable timely deployment of lessons learned.
• Measure standard adoption, technology deployment, network capability, inspection outcomes, contamination-control performance, and repeat findings.
• Lead the monthly ACE network meeting and quarterly governance review with the Chief Quality Officer and key functional leaders.
• Initiate an event-driven technical review within 24 hours for a serious contamination, sterility, or microbiological event, or another issue that may compromise sterility assurance.
• Lead the technical response to significant events and provide strategic direction during inspections, remediation, and quality transformation initiatives.
• Recommend suspension of aseptic operations or distribution holds when sterility assurance may be compromised, jointly with accountable site Quality and Operations leadership, with escalation to the Chief Quality Officer.
• Approve critical technical requirements within the ACE mandate and support development of corporate and site procedures needed to implement global standards.
• Qualify and oversee external partners performing aseptic or sterility assurance work, especially following significant quality events.
• Provide functional matrix leadership to site microbiology managers, sterility assurance leaders, and designated aseptic representatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Director