Manager, Quality - External Manufacturing

Posted on : Thursday, April 6, 2023 Organization : Bausch + Lomb Location : Rochester, NY Description :

Position Summary :

The Manager - External Manufacturing Quality will manage a group of quality professionals responsible for the quality performance of Bausch & Lomb's Finished Goods (FG) / External Manufacturing (EM) suppliers for Pharmaceutical and Consumer products.

The manager will lead and will be responsible for the execution of quality-related activities including supplier or product related issues and investigations, product and process improvement / acceptance activities, supplier qualifications, quality agreements, training, deviations, CAPA, change management and problem solving.

Key responsibilities :

• Manage and lead of implementation of effective quality control systems at the Consumer / Pharma / EM supplier sites to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
• Ensure Finished Good / External Manufacturing suppliers are compliant to all regulatory (US and International) and Bausch Lomb requirements
• Coordinate all activities with the supplier management team and identifying improvement opportunities.
• Manage and lead improvements for Supplier Quality practices to ensure compliance for all products
• Ensure completion of investigations, non-conformances and CAPAs related to FG / EM suppliers within required timelines.
• Identify and implement effective supplier quality management systems at the EM supplier sites to support due diligence, supplier selection, qualification, monitoring, disqualification, supplier risk management and mitigation activities in order to ensure a sustainable and compliant supplier quality management system with Bausch & Lomb EM suppliers.
• Provide technical mentorship in resolving quality supply chain issues.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with FG / EM suppliers.
• Assist EM QA functions, supply chain and R&D organizations in sourcing new FG / EM suppliers.

Requirements :

Qualifications / experience :

• Bachelors degree in a relevant discipline is required
• A minimum of 8 years within a supplier quality organization (minimum 4 years in the Pharmaceutical industry is required).
• A minimum of 4 years in a management position is preferred.
• Demonstrated expertise in implementing and maintaining quality systems with emphasis in supplier management controls.
• Ability to travel to supplier sites is required.
• Proven track record of successfully working with cross functional teams in a fast paced and dynamic environment.
• Familiarity with 21 CFR Part 210, 211, 820, ISO 13485, ISO 14971.
• Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) and ability to mentor stakeholders in analysis of process data and metrics to identify root cause of complex problems and in the development and implementation of preventative or corrective actions.
• Expertise in providing creative solutions to complex issues.
30+ days ago