Senior Site Quality Excellence Lead

EPM Scientific; Hauppauge (NY); On-site; USD 140,000 - 180,000; Full time

Job summary

EPM Scientific is seeking a Senior Manager, Quality Excellence to lead the quality function at a key manufacturing site in the life sciences sector. You will act as the site Quality Management Representative, overseeing QA/QC, Quality Engineering and Quality Laboratory to ensure regulatory compliance and continuous improvement.

You will drive the QMS across procedures and IT systems, partner with global leadership, lead audits, and develop a high-performing team focused on data-driven decisions,

Qualifications

• Bachelor's degree in Science or Engineering or 10+ years of equivalent experience in a regulated manufacturing environment.
• 7+ years' experience in Quality, Quality Engineering or Manufacturing Operations within Life Sciences or FDA/EPA-regulated setting.
• 5+ years' leadership, incl. 2 years leading Quality Engineering and Quality Laboratory teams.
• Strong knowledge of ISO 9001 & ISO 13485, FDA regulations, cGMPs and CFR requirements.
• Proficiency in quality statistical methods, Lean, Six Sigma, Gage R&R and Root Cause Analysis.
• Proven ability to lead, coach and mentor teams and communicate at all levels.

Responsibilities

• Lead QA/QC, Quality Engineering and Quality Laboratory functions to ensure regulatory compliance and customer satisfaction.
• Implement, maintain and optimize the Quality Management System (QMS) to support site operations.
• Collaborate with site and global leadership to address process changes and drive customer-centric solutions.
• Build a high-performing quality department with focus on safety, development and continuous improvement.
• Lead Quality Management Reviews, define KPIs, host audits, and manage risk assessments at the site.

Skills

Quality leadership

Team development

Cross-functional collaboration

Problem solving

Data-driven decisions

Education

Bachelor's degree in Science or Engineering

Job description

EPM Scientific is seeking a Senior Manager, Quality Excellence to lead the quality function at a key manufacturing site in the life sciences sector. You will act as the site Quality Management Representative, overseeing QA/QC, Quality Engineering and Quality Laboratory to ensure regulatory compliance and continuous improvement.

You will drive the QMS across procedures and IT systems, partner with global leadership, lead audits, and develop a high-performing team focused on data-driven decisions,