Multi-Site Quality Manager

The Multi-Site Plant Quality Manager will ensure the effective implementation of the Quality Management System in alignment with regulatory and corporate requirements across Two manufacturing locations.

Will proactively identify and report areas of concern to management while driving compliance with ISO 13485, customer specifications, and corporate quality procedures. Will be the point of contact for customer quality escalations.

Will develop and implement consistent quality systems across to enhance operational efficiency and support strategic initiatives as guided by the BPS Quality Director. Will lead, train, and develop quality teams at multiple locations, fostering a culture of continuous improvement.

Overview

• Implementation and oversight of a Quality Management System that operates in compliance with corporate quality policies and procedures, as well as relevant regulatory requirements (ISO:13485) and industry guidance.
• Oversee and manage Quality department personnel at each site, including Quality Lab, Supplier Quality, Quality Engineering, and Focus Factory Quality Engineers.
• Develop and implement consistent quality systems across all sites to enhance operational efficiency.
• Support the BPS Director of Quality in development and deployment of policies and procedures for elements of the global QMS.
• Support strategic initiatives as guided by the BPS Director of Quality.
• Promote and enforce a safe working environment, including proper use of PPE and active participation in department safety meetings.
• Investigate and report incidents while ensuring compliance with Environmental Management System (EMS) requirements and best environmental practices.
• Implementation of document control and review/approval of controlled documents.
• Implementation of ECO process including change management and review of all change controls.
• Implementation of supplier quality management and performance of supplier audits as appropriate.
• Complaint management includes robust root cause analysis and CAPA.
• Ensure robust root cause analysis investigation and CAPA for deviations and nonconforming product.
• Implementation of effective Internal Audit Program.
• Ensure adequate training program is in place.
• Implementation of an applicable Validation Master Plan including equipment, process, product, sterilization and test methods.
• Oversight of cleanroom practices including qualification, monitoring, and behavior.
• Implementation of Quality Risk Management in relevant aspects of the QMS.
• Maintenance of the Global QMS e-tool (ETQ) at the plant.
• Execute talent management activities with direct reports. Ensure proper performance management, training, and development of direct reports.
• Customer Management includes facilitating/host customer audits, ensuring timely, robust and effective corrective action to customer audit observations, review/approve quality agreements with customers, partner in the resolution of quality issues and requests.
• Critical Events and complaint management
  
  

Requirements

• Bachelor's Degree in Life Sciences related field (Chemistry, Biology, Microbiology), Engineering, Quality, Operations Management or other applicable degree with Life Sciences experience; required.
• 10 years of experience in a Quality function in Quality System design, development, implementation role or progressive roles held in an operations site; required.
• 8 years of experience in a regulated industry with preferred emphasis in life sciences (e.g., pharma, biopharm, or medical device); required.
• 5 years of direct supervisory experience.
• Strong knowledge of ISO (ISO 13485 specifically required) and cGMP requirements and relevant industry standard practices are required. Must have the ability to interpret these regulations to ensure proper implementation in the plant systems; required.
• The client offers a competitive salary package that is dependent on qualifications and experience, as well as a strong benefit package, plus participation in a company-wide bonus plan. For immediate consideration and faster response, please forward current resume to: sb@scientificsearch.com. Please include job #19632 in subject line. Please note that all candidates applying must be a US Citizen or Permanent Resident. Client will NOT sponsor.