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 nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 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.

Position Summary

The External Manufacturing Sr. Supplier Quality Specialist will work directly with Bausch + Lomb's External Manufacturing (EM) suppliers, to provide routine support related to commercial product and new product introduction. This position will work directly with EMs to ensure finished goods External Manufacturing suppliers are compliant to all regulatory and Bausch + Lomb's requirements. In addition, the position is responsible for measuring and reporting key quality metrics to drive quality and efficiency.

Key Responsibilities

• Track and Trend all quality Inputs (Non-conformances, CAPAs, root cause, change management) and Identify adverse trends and institute corrective
• Assist quality management in all audits (FDA, Notified Body, other Regulatory agencies, License customer audit) that occur at company sites.
• Support supplier management teams in identifying opportunities for improvements.
• Provide technical mentorship in resolving quality supply chain issues between Bausch + Lomb and FG/EM suppliers.
• Ensure Finished Good/External Manufacturing suppliers are compliant to all Regulatory and Bausch + Lomb requirements.
• Directly support management team for activities related to Annual Product Reviews, Management Review, Complaint Review Board, Material Review Board, Local Change Board and Critical Action Committee.
• Proactively investigate, identify and implement best-in-class Quality practices.
• Ensure that supplier qualification process performed for all suppliers
• Perform supplier qualification activities including but not limited to :quality agreement, qualification and surveillance audits
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with FG/EM suppliers.
• Escalate critical quality issues from EM suppliers to Senior Quality Management.
• Complete batch releases, non-conformances, quality change requests and CAPAs including root cause investigations related to FG/EM suppliers within required timelines.
• Identify and implement effective quality systems at EM supplier sites to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.

Qualifications/experience

• Expertise in providing creative solutions to complex issues.
• Experience in electronic quality system modules such as Compliance Wire, Trackwise, Documentum, etc.
• A minimum of 5 years’ experience within a pharmaceutical or medical device Quality organization is required.
• ASQ Certification preferred but not required (such as CQA, CQE, CMQ/QE)
• Hands on floor experience in supplier quality is preferred.
• Demonstrated expertise in implementing and maintaining quality systems with emphasis in supplier management controls.
• Bachelor’s degree in relevant discipline or related technical field (microbiology, chemistry, mechanical, etc) is required.
• Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes).
• Proven track record of successfully working with cross functional teams in a fast paced and dynamic environment.
• 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 origin, disability, or veteran status.

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To learn more please read Bausch+Lomb's Job Offer Fraud Statement .

Our Benefit Programs: https://www.bausch.com/careers/benefits/

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.