Quality Assurance Supervisor

About the role

Onsite in Flanders, NJ. We’re looking for a hands-on, meticulous Quality Assurance Supervisor who is passionate about setting up quality systems. You’ll play a key role in developing and implementing our Quality Management System (QMS), preparing for pre-approval inspections, and supporting new product development.

Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS).
• Drive the transition from paper-based to electronic systems (LIMS, TrackWise).
• Conduct internal audits and ensure inspection readiness (PAI, regulatory).
• Ensure compliance with cGMP and industry standards.
• Review and approve SOPs, batch records, deviations, and change controls.
• Analyze quality data to identify trends and drive continuous improvement.
• Develop and implement Corrective and Preventive Actions (CAPA).
• Coordinate with other departments to resolve quality issues quickly and effectively.
• Prepare and present quality performance reports to management.
• Train and mentor QA staff to build a culture of quality and excellence.

Requirements

• Bachelor’s degree in a related field.
• 3–5 years of experience in pharma QA supporting drug product development and manufacturing.
• Proven experience in establishing or managing Quality Systems and preparing for audits/inspections.
• Strong understanding of GMP, QMS, and ISO 9001 standards.
• Hands-on experience with LIMS, TrackWise, or other eQMS tools.
• Excellent leadership, communication, and problem-solving skills.
• Highly meticulous, data-driven, and comfortable in a fast-paced, startup-like environment.

Benefits

• Be part of a core leadership team with exciting growth plans for the future.
• Shape a modern, digital-first Quality Management System.
• Collaborate with experienced professionals passionate about quality and innovation.
• Competitive compensation and long-term career growth opportunities.