Site Quality Head

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

A global leader in life sciences and biotechnology is looking for a Senior Manager, Quality Excellence to lead the quality function at one of its key manufacturing sites.

This is a genuine site leadership role. You'll act as the site's Quality Management Representative, leading the Quality Assurance, Quality Control and Quality Laboratory teams, and ensuring the Quality Management System is compliant, robust and continuously improving. You'll be the go-to quality leader on-site - partnering with global leadership, hosting audits, and building a high-performing team that takes real pride in what it does.

If you're a quality leader who enjoys blending compliance, continuous improvement and people development, this is a fantastic platform to make your mark.

What You'll Do

• Quality Leadership & Compliance: Serve as the site's Quality Management Representative, leading QA/QC, Quality Engineering and Quality Laboratory functions to ensure regulatory compliance, customer satisfaction and alignment with organisational goals.
• Quality Management System (QMS): Implement, maintain and optimise the QMS, ensuring procedures, work instructions and IT systems support site operations and drive continuous improvement.
• Strategic Partnership & Advocacy: Collaborate with site and global leadership to address process changes, advocate for site-specific needs, and drive customer-centric solutions during change management and product development.
• Team Development & Performance: Build a high-performing quality department, fostering a safe, empowering environment that encourages skill development, psychological and physical safety, and continuous improvement.
• Audits, Reporting, Risk & Representation: Lead Quality Management Reviews, define and monitor KPIs, host audits, lead risk assessments, and represent the site in executive discussions and global best-practice initiatives.

What You'll Bring

• Bachelor's degree, ideally in Science or Engineering - or 10+ years of equivalent experience within a regulated manufacturing environment.
• At least 7 years' experience in Quality, Quality Engineering or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device, Biopharma or another FDA/EPA-regulated environment.
• Minimum 5 years' leadership experience, with 2 years leading both Quality Engineering and Quality Laboratory teams preferred.
• Strong knowledge of ISO 9001 & ISO 13485, FDA regulations, cGMPs and CFR requirements, including operational controls, validation, CAPA, complaints, audits and risk management.
• Proficiency in quality statistical methods, Lean Manufacturing, Six Sigma, Gage R&R and Root Cause Analysis tools to drive data-driven decisions.
• Proven ability to lead, coach and mentor teams, manage performance, plan succession and communicate effectively at all levels.