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 summary:
The Senior Principal Quality Engineer serves as a quality expert globally for pharma/consumer processes and product compliance. This role owns and is responsible for working directly with Global Quality Operations leadership and multiple functions/levels across the B+L organization to ensure the efficient and effective execution of the quality processes/activities.
Key responsibilities:
• Collaborates within Quality and across Regulatory Affairs, Manufacturing Operations and Supply Chain to provide interpretation and application for strategic and tactical decisions regarding industry best practices, new regulations, and processes in end-to-end QMS establishment and execution; pharma QMS input, provides a proactive and fit for purpose approach:
• Quality oversight/governance for pharma products/processes by actively monitoring and assessing quality performance and compliance results, inclusive of oversight and monitoring of Pharma/Consumer product complaints.
• Pharma product quality escalation process and event management.
• Pharma product global recall process ownership, oversight, and guidance.
• Provide input and review of health authority communication and Inspection responses.
• Act as Qualified Individual for the Foreign Supplier Verification Program for dietary supplements imported to the U.S.
• Rx Samples, US – QMS Quality Engineer support and oversight/monitoring of PDMA compliance.
• Manage Pharma Quality assessment process for new and/or revised regulations/standards.
• Initiates/supports QMS/Compliance improvement projects to enhance performance and/or mitigate compliance risks, where/when applicable
• US FDA Point of Contact designee for B+L Bridgewater facility.
Qualifications and experience:
• bachelor’s degree in engineering or science field related to pharmaceutical products required.
• Minimum of 10 years of experience within the Quality organization in a global pharmaceutical company required, with at least 5 of those years in a Quality Operations role within a pharmaceutical manufacturing facility, preferably aseptic.
• Working knowledge of pharmaceutical regulations globally.
• Strong leadership skills, including the ability to lead and influence, implement change with cross functional stakeholders.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to work in geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Medical device experience and combination product experience, a plus
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.
A remote work option is available.
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 (https://hcm2preview.sapsf.eu/bauschhealT4/Bausch_job_posting_statement.docx) .
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.