Job Information
Bausch + Lomb Manager, Quality Assurance in Rochester, New York
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.
Position overview:
The Manager, Stability Operations and Reference Standards will manage the people and the facilities that support the on-going stability programs for Bausch + Lomb vision care solutions (510(k)) and pharmaceutical (NDA, ANDA) stability studies for registration and annual commitment programs. Additionally, this position manages a global reference standard program that distributes reference standards to support the programs on stability.
Primary responsibilities include:
• Lead a team of stability operations and reference standards professionals
• Manage a GMP compliant stability program for both medical device and pharmaceutical programs including the physical chambers, the product in them, the data that is generated from the samples that are a part of the program, the protocols that govern the samples, the software used to manage the program, statistical evaluation of the data, etc.
• Recommend testing requirements on a global level for new programs in development, establish stability strategies for teams to efficiently plan for stability studies during registration to meet global needs.
• Assures training of all team members for assignments and for development opportunities.
• Plans for cross training in the team to allow for coverage of key tasks
• Provides oversight of ongoing R&D activities at the site to assure GMP activities are appropriate to phase of project and are escalated where necessary.
• Manages processes within the quality management systems appropriately.
• Maintains on the job knowledge and skills by participating in review of applicable training and regulations
• Supports internal and external regulatory audits of function
• Partners with laboratory operations leaders to deliver samples and improve processes for the best customer partnership efficiently and effectively.
• Establishes a stability central leadership function with other stability groups within the B+L network for best practice sharing.
• Lead and advance the reference standard program
• Distribute GMP-certified reference standards to support our global business for pharmaceutical and medical device testing
Qualifications and experience:
• BS in quality sciences or scientific-related field, with 10 years additional experience and 5+ years of leadership experience in a GMP industry with stability-specific experience.
Experience may include:
• Previous work in stability operations
• Work in a GMP laboratory in the medical device or pharma industry
• Quality experience in the medical device or pharma industry
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.
As required by New York State's pay transparency bill, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in New York State. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For New York State, the range of starting annual base pay for this role is $105,000 - $155,000
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To learn more please read Bausch+Lomb's Job Offer Fraud Statement (https://hcm2preview.sapsf.eu/bauschhealT4/Bausch_job_posting_statement.docx) .
Our Benefit Programs: https://www.bausch.com/careers/benefits/
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