Director, Quality

Bausch+Lomb Companies Inc.•Tampa, FL

10d

About The Position

The Director, Quality leads Bausch + Lomb’s Global Aseptic Center of Excellence (ACE) and serves as the accountable enterprise leader for aseptic processing, sterility assurance, and microbiology governance across applicable sterile pharmaceutical and sterile medical device manufacturing operations. The role provides enterprise leadership, technical authority, governance, and strategic direction; establishes consistent, science-based, risk-based standards; and harmonizes 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 consistent company-wide aseptic and sterility assurance system. The Director establishes and maintains the enterprise contamination control strategy framework and global standards; reviews and approves site strategies and specified revisions or waivers; harmonizes monitoring, microbiology, disinfection, sanitization, gowning, filtration, endotoxin-control, sterilization, container-closure-integrity, and aseptic-process-simulation programs; and provides technical authority on facilities, barriers, utilities, validation, and sterilization and bio-decontamination cycles. The role designs global training and qualification programs and drives adoption of emerging technologies, automation, and digital data systems. The Director defines common global performance indicators and uses enterprise trending and benchmarking to identify emerging risks, reduce recurring nonconformances, and deploy lessons learned. The role leads ACE governance and technical responses to significant events, supports inspections and remediation, and may recommend suspension of aseptic operations or distribution holds jointly with accountable site Quality and Operations leadership, escalating to the Chief Quality Officer as needed. It also provides functional matrix leadership to site microbiology managers, sterility assurance leaders, and designated aseptic representatives. The position provides enterprise technical authority and governance without replacing 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 submission ownership.

Requirements

Bachelor's degree in Microbiology, Biology, Engineering, Pharmacy, or a related scientific discipline.
At least 15 years of progressive experience in microbiology, contamination control, aseptic processing, sterilization, and sterility assurance within sterile pharmaceutical and/or sterile medical device manufacturing, including 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.
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; visa sponsorship or takeover of sponsorship is not available.

Nice To Haves

Advanced degree.

Responsibilities

Establish and maintain the enterprise contamination control strategy (CCS) framework and global standards aligned with applicable regulatory and industry requirements.
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.
Develop a repeatable 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 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 for contamination, 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 deploy lessons learned.
Measure standard adoption, technology deployment, network capability, inspection outcomes, contamination-control performance, and repeat findings.
Lead monthly ACE network meetings and quarterly governance reviews with the Chief Quality Officer and key functional leaders.
Initiate an event-driven technical review within 24 hours for serious contamination, sterility, microbiological, or other events that may compromise sterility assurance.
Lead the technical response to significant events and provide strategic direction during inspections, remediation, and quality transformation initiatives.
Jointly recommend suspension of aseptic operations or distribution holds when sterility assurance may be compromised, with accountable site Quality and Operations leadership, and escalate to the Chief Quality Officer.
Approve critical technical requirements within the ACE mandate and support development of corporate and site procedures implementing 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.