Senior Quality Specialist, Supply Chain

Quality Assurance Manager

Bausch + Lomb 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.

Purpose Of Job :

Supports the maintenance of the site quality systems to assure compliance with applicable regulatory requirements, standards and Bausch + Lomb QMS requirements.

Management of various logistic providers globally inclusive of 3PLs (re-packagers / re-labelers), distributors, and transportation providers to ensure consistent delivery of goods and services to meet quality standards using a proactive and collaborative approach with various stakeholders.

Key Activities :

Support the development, implementation and maintenance of efficient, effective and compliant quality systems at the distribution level supporting product record reviews / system release.

Release of product for distribution across business units, non-conformance / CAPA management, change management, document management, records management, data integrity, risk management and training.

Additional support / oversight regarding product / process investigations, supplier management, internal / corporate / external audit support, process / continuous improvement, compilation of site quality / compliance metrics, including management reviews.

Provide quality support to inventory control, when necessary as well as evaluate / approve damaged, aged or expired product for destruction, both internally and with third party logistics centers.

Develop, implement, and maintain global logistics standards across supply chain quality (storage & transportation, to include global guidance on managing shipping lanes and temperature excursions during transport, etc.)

Develop, implement, and maintain supplier management in company systems (Catsweb) for these suppliers.

Arrange & conduct 3PLs, distributor and transportation supplier qualifications.

Create, update, and maintain quality agreements.

Manage supplier audit program for 3PLs, datalogger, and transport providers.

Ensure good distribution practices (GDP), temperature controls, results, and traceability requirements are established and monitored.

Provide supplier performance results & escalate issue to management, when appropriate.

Propose solutions with action plans to resolve, when appropriate.

Manage and / or participate in projects to continuously improve logistics (storage and transport).

Active member of global distribution QMS team.

Qualifications :

Bachelors degree in science or related field.

Minimum 5 years experience in quality in an FDA regulated industry.

Minimum of 3 years distribution center / logistics experience, inclusive of processes & electronic systems for distribution and inventory management.

ASQ certification (eg, CQA, CQE) desirable / ISO certified lead auditor desirable.

Strong analytical & computer skills to include Windows, Word, Excel, PowerPoint, etc.

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.