Onsite GMP QC Quality Manager – Cranbury

Regulatory Jobs; Cranbury Township (NJ); Sur place; USD 104 000 - 140 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits package

401(k) with company match

Employee stock purchase plan

Paid time off and holidays

Résumé du poste

Thermo Fisher Scientific is seeking a Quality Manager for the Cranbury, NJ site. You will lead Quality Assurance and Quality Control, guiding investigations, CAPAs, and change controls while ensuring ISO 9001 alignment and continuous improvement across the PeproGMP portfolio.

You will collaborate with Operations, R&D, Regulatory Affairs and other functions to enhance product quality, data integrity, and customer outcomes in a regulated GMP environment.

Qualifications

• 7+ years in Quality Assurance or Quality Control in life sciences/manufacturing.
• 2+ years of people leadership and team development.
• Experience applying GMP requirements and 21 CFR Part 820/QMSR.
• Experience supporting ISO 9001 and audit readiness.

Responsabilités

• Provide leadership for Quality Assurance and QC at Cranbury site.
• Lead and develop the Cranbury Quality Control team and testing operations.
• Maintain QMS and ISO 9001 certification; drive continuous improvement.
• Oversee investigations, CAPAs, deviations, change controls and customer complaints.
• Analyze data to identify risks and drive quality improvements across manufacturing.

Connaissances

Quality Assurance

GMP knowledge

Leadership

Cross-functional collaboration

Regulatory affairs

Quality systems

Risk management

Formation

Bachelor's degree in Science or related field

Advanced degree preferred

Outils

Quality Management System (QMS) software

Description du poste

Thermo Fisher Scientific is seeking a Quality Manager for the Cranbury, NJ site. You will lead Quality Assurance and Quality Control, guiding investigations, CAPAs, and change controls while ensuring ISO 9001 alignment and continuous improvement across the PeproGMP portfolio.

You will collaborate with Operations, R&D, Regulatory Affairs and other functions to enhance product quality, data integrity, and customer outcomes in a regulated GMP environment.