Job description

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 worldfrom 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 Sr Clinical Quality Specialist supports the Clinical Quality Assurance function within Research and Development Operations with primary responsibility for managing non-conformance and change control systems and providing GCP guidance for day-to-day operations. Secondary responsibilities include supporting GCP training, conducting system, study, site, and vendor audits.

Key responsibilities:
Maintain effective strategies, systems, and procedures, ensuring compliance with applicable GCP standards

Support internal and regulatory inspections.

Secure and utilize consultant resources to ensure audits are completed on time and with excellence.

Support audited groups in developing effective, risk-based corrective actions.

Authors/reviews summary reports, memos, and standard operating procedures.

Partner with key customer groups in Clinical Operations to develop and meet quality objectives.

Develop and track key quality performance metrics to identify trends and mitigate emerging quality issues.

Evaluates and improves existing processes with limited guidance

Qualifications/experience:
BS/BA in related discipline.

Working knowledge of GCP regulations/guidelines (ICH, US FDA, ISO).

Minimum of 5 years of experience in Quality related positions including at least 3 years working directly with GCP regulations

Clinical Research Certification strongly desired

Strong computer skills.

Excellent communication (verbal and written) skills and ability to work effectively on teams.

\#LI-CJ1

This position may be available in the following location(s): [[location_obj]]

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.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

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

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