Quality Assurance & Compliance Specialist

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 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.

Objectives / Purpose of Job :

The Quality Compliance Specialist is responsible for ensuring that the organization's Quality Management System (QMS) is compliant with applicable regulatory requirements and site standards such as but not limited to (FDA, cGMP, ICH, etc.) and internal policies. This role supports internal and external audits, maintains compliance documentation, and drives continuous improvements related to inspections readiness initiatives.

Responsible for various Quality System process improvements and Quality Assurance / System projects, which will require cross-functional work with support teams to develop and improve Quality Systems processes and Inspection Readiness.

Key Activities / Responsibilities :

Quality Management System (QMS)

Serve as a back up to for QMS elements such as Quality Change Control, Annual Product Reviews, Quality by Design initiatives and CoA / CoC creations.

Prepare, review, and update Standard Operating Procedures (SOPs), as deemed required.

Lead and participate in investigations stemming from QMS systems

Audits & Inspections

Coordinate and participate in internal audits.

Support external inspections, including preparation of SMEs, audit logistics, and response development.

Assist with tracking and facilitating closure of audit findings and observations.

Continuous Improvement

Identify compliance gaps and recommend corrective / preventive actions.

Develop, track and use leading indicators to drive compliance and continuous improvement for site readiness

Collaborate with cross functional teams to develop and ensure mature QMS systems

General

Complete assigned training by the assigned due date performs other duties as assigned.

Qualifications / Training :

• Minimum of BA / BS
• 5+ years' experience in Quality Systems and Batch Record Review in a pharmaceutical manufacturing organization.
• High level of competency of MS office applications such as MS Word, Excel and Access
• 5+ years of experience Pharmaceutical Manufacturing GMP Environment or equivalent.
• Adept with presentation skills to deliver broad material to an audience.
• Experience with other Pharmaceutical Manufacturing Quality Systems.
• Aseptic processing knowledge 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.

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 : Employee Benefits : Bausch + Lomb

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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