Quality Assurance SupervisorOnsite in Flanders, NJWe're looking for a Quality Assurance Supervisor who's hands-on, meticulous, and 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.
What You'll Do- 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.
What You'll Bring- Bachelor's degree in 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.
