Bausch + Lomb France · 13 hours ago
Manager, Quality Assurance
Greenville, SC
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expBausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight. They are seeking a Manager of Manufacturing Quality Assurance responsible for quality oversight of Manufacturing Operations within the Greenville Solutions Facility, ensuring compliance with regulations and leading quality initiatives.
Medical Device
No H1B
Responsibilities
Ensure that a robust product disposition process is executed for all product that is available for distribution
Work with Operations and the MRB (as appropriate) to ensure sound and timely decisions are made regarding product impact, product release and overall risk analysis
Ensure that all customer complaints are thoroughly investigated, where applicable
Ensure detailed, thorough investigations are completed to current industry expectations and in a timely manner within the site's Manufacturing Operation
Ensure that the department maintains compliance with associated regulations from the site standards list and industry best practices, while conducting gap assessments
Ensure that the risk management program remains current with regulatory, global, and local requirements and assessments
Interface with outside regulatory and legal authorities as appropriate
Will provide leadership to Greenville Operations on cGMP and other compliance requirements
Oversee the performance of department staff
Establish, manage and monitor departmental budget and spending against stated variances
Establish, communicate and execute against strategic quality and site objectives
Identify, evaluate, select and implement against continuous improvement and compliance initiatives
Qualification
Required
Minimum of a B.S. degree, scientific or engineering degree
10+ years of experience managing quality systems or directly associated with manufacturing or manufacturing quality in a sterile dosage pharmaceutical or medical device facility. (i.e., 21CFR211, 21CFR820, ISO 9001, ISO 13485)
Experience in leading, conducting and writing investigations
Preferred
Certifications preferred: CQA, CQE, CQM
Benefits
Employee Benefits: Bausch + Lomb
Company
Bausch + Lomb France
Bausch+Lomb, c’est avant tout un laboratoire dédié à la protection et à l’amélioration de la vue de millions de personnes dans le monde, pour les accompagner dès leur naissance et à chaque phase de leur vie.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase