Quality Assurance Supervisor - Manufacturing

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.

Purpose of Job:

The role of Manufacturing Quality Assurance (MQA) Supervisor is integral to the on-going compliance of the manufacturing and distribution processes. The MQA Supervisor is involved in the following stages of the product life cycle --- manufacturing support, and post-launch maintenance.

Key Activities:

• Supervise the MQA Product Release and MQA Line Inspection groups.

• Ensure timely release of manufacturing batches to support release timelines and distribution requirements.

• Supports/leads investigations using root cause analysis tools and proposing/implementing systemic corrective actions. Responsible for implementing corrections and corrective actions associated with Product Release and Inspection activities.

• Provides routine analysis of performance indicators. Presents this information to management, supervisors, and manufacturing operators.

• Review, revise and approve procedures and specifications as needed. Communicates and implements the document/process changes with the department and operations.

• Manage the site's retain program and manage the site's collection of samples to support the stability program.

• Identify, evaluate, and implement continuous improvement and compliance initiatives.

• Ensures that decisions are made based on sound Quality principles and regulatory guidelines.

• Monitor daily operation activities to ensure compliance to applicable CFRs, ISO requirements, and local/global quality system requirements.

• Interview, hire and support a qualified department staff. Manage performance evaluations and monitor performance and development of direct reports.

• Establish, manage, and monitor departmental budget and spending against stated variances.

Scope of Position:

• Size of Team: Supervises 10 MQA Line Inspectors and 10 MQA Release Coordinators. Direct reports span multi-shifts/weekends so some presence on non-routine work hours may be expected to support operations and appropriately manage direct reports.

• Responsibility is limited to Greenville Solutions Facility and associated QA inspection activities at the Greenville Distribution facility.

• Role has budget responsibility for department spending.

Qualifications:

• Four-year college degree (BA/BS) required in fields such as life, physical sciences, or engineering.

• Previous supervisory experience required either in a quality or an operations/manufacturing role.

• Minimum 5 years' QA experience required, in a medical device or pharmaceutical manufacturing environment. Specific experience in aseptic operations and/or packaging operations is a plus.

• Experience in the following regulations: 21CFR210, 21CFR211, 21CFR820 or ISO 13485.

• Experience leading, conducting, and writing nonconformance investigations and development/implementation of CAPAs.

• Experience in incoming and/or finished product inspection with use of sampling plans is preferred.

• Should have experience in a contract manufacturing and/or distribution operations.

• Should have experience with computerized inventory and warehouse systems.

• Should have experience with automated quality management/documentation systems.

• Special Skills: Detail oriented, well organized, and the ability to multi-task and shift priorities when needed to meet operational requirements and customer demand.

This position may be available in the following location(s): US - Greenville, SC (Plant)

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.

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.

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