Senior Supplier Quality Specialist

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.

The External Manufacturing Senior Supplier Quality Specialist will work directly with Bausch & Lomb's Finished Good (FG)/External Manufacturing (EM) suppliers of Pharmaceutical and Consumer products, to provide sustaining quality and compliance leadership, and routine support related to global commercialized products. The position will support the global strategy for product launches and will lead the execution of quality-related activities, including but not limited to, supplier or product related issues and investigations, product and process improvement/acceptance activities, batch releases / batch record reviews, supplier qualifications, conduct audits, site evaluation once needed, quality agreements, training, deviations, CAPA, change management, perform annual product reviews, and report key quality metrics to drive quality and efficiency.

• Identify and lead implementation of effective quality systems at the Consumer /Medical Device/Pharma/EM supplier sites to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
• Ensure Finished Good/External Manufacturing suppliers are compliant to all regulatory (US and International) and Bausch + Lomb requirements
• Support supplier management team in identifying opportunities for improvements.
• Complete batch releases, investigations, non-conformances and CAPAs related to FG/EM suppliers within required timelines
• Support, qualification, audits, performance monitoring, risk management and mitigation activities
• Proactively investigate, identify and implement continuous improvements in supplier quality management practices to ensure product compliance
• Provide quality support in resolving quality supply chain issues between B+L and FG/EM suppliers
• Escalate critical quality issues from EM suppliers to Quality Leadership
• Ensure timely completion of investigations, non-conformances, corrective and preventive actions as well as effectiveness verification activities
• Lead quality change request management activities
• Track and trend quality performance indicators to identify adverse trends
• Perform Annual Product Reviews
• Assist supply chain and R&D organizations in sourcing new FG/EM suppliers
• Assist quality management in all B+L site audits (FDA, Notified Body, other Regulatory agencies) and supplier audits
• Directly support management team for activities related to Management Review, Complaint Review Board and Critical Action Committee

• Bachelor of Science degree in a pharmaceutical discipline (Industrial Pharmacy, etc.) or related technical field (chemistry, microbiology, etc.) is required.
• ASQ Certification preferred (such as CQA, CQE, CMQ/QE).
• Excellent communication skills (verbal and written).
• Ability to successfully influence others within project teams regarding quality or compliance concerns.
• Excellent organizations and presentation skills. identifying root cause, implementing corrective and preventative actions and performing effective verification activities.
• A minimum of 5 years within a supplier quality organization (minimum 3 years in the pharmaceutical industry is required). knowledge in aseptic environments is needed
• Demonstrated expertise in Implementing and maintaining quality systems with emphasis in Supplier management controls.
• Proven track record of successfully working with cross functional teams in a fast paced and dynamic environment.
• Familiarity with 21 CFR Part 210, 211, 820, ISO 13485, ISO 14971.
• experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes).
• Ability to travel to supplier sites as required.

This position may be available in the following location(s): US - Rochester, NY (GEHC)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national…