Address
Form of workBausch + 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 Principal Quality Auditor is a key member of the Quality Compliance team and is responsible for assessing Bausch + Lomb manufacturing sites, distribution centers, applicable affiliates, and global functions for GxP compliance to the applicable country regulations, the applicable ISO standards, and the applicable Quality Management System requirements and elements to determine risk, opportunities for improvement and best practices.
Key responsibilities:
Prepare, plan, and conduct effective and efficient GxP quality compliance audits of company manufacturing sites, distribution centers, applicable affiliates and global functions.
Through the audit program, assess the site or function's compliance risk. Communicate the assessment results inclusive of risks, learnings, best practices, etc. to our customers (Senior Management, Site or Functional Management, etc.)
Prepare and distribute audit reports.
Review and approve auditee responses/CAPA plans.
Maintain working knowledge of applicable regulations and standards affecting company sites and global functions.
Back-up for preparation and maintenance of the audit schedule per applicable procedure.
Back-up for the creation and update of departmental and global procedures, as needed.
Active participation on the Technical Auditor Forum.
Assist in preparing and hosting external inspections (FDA, Notified Body, etc.), as needed.
Ability to learn and use the company's enterprise Quality Systems software applications.
Qualifications and experience:
Bachelor's Degree, preferred degree in a science discipline, microbiology or chemistry preferred.
Certified auditor (ASQ CQA, IRCA, or equivalent).
Minimum of 8 years of experience in the medical device and/or pharmaceutical industry, with aseptic manufacturing experience preferred.
Experience in Quality roles required. Manager of Quality or Quality Area is a plus.
At least 3 years Lead Auditor experience in a medical device or pharmaceutical environment.
Working knowledge of US FDA regulations (21 CFR 210, 211 and 820).
Working knowledge of other country regulations (examples - Europe, Canada, Japan, Brazil, Australia, etc.).
Working knowledge of ISO 13485 and 14971.
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 $94,000 - $144,000
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
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.
