Quality & Compliance Leader, GMP/ISO 9001

ThermoFisher Scientific; Cranbury Township (NJ); On-site; USD 104,000 - 140,000; Full time

Benefits offered by this job

Medical & dental plans

Vision plan

Employee stock purchase plan

Job summary

Thermo Fisher Scientific in Cranbury, NJ is seeking a seasoned Quality Manager to lead the Quality Assurance and Quality Control functions for PeproGMP products. You will drive compliance, investigations, CAPAs, and continuous improvement across manufacturing and laboratory operations.

The role partners with Operations, Regulatory Affairs, R&D, and cross-functional teams to resolve quality issues, steward ISO 9001 certification, and ensure data integrity and patient safety.

Qualifications

• Bachelor’s degree in Science, Engineering, Biochemistry, Biotechnology, Microbiology, Biomedical Engineering, or related field.
• Advanced degree preferred.
• Minimum of 7 years in Quality Assurance, Quality Control, or related Quality functions in life sciences.
• At least 3 years of people leadership experience.
• Experience with GMP, ISO 9001, and audits.
• Experience with electronic records and data integrity (21 CFR Part 11).
• Strong cross-functional leadership and problem solving.

Responsibilities

• Provide Quality leadership for QA and QC activities supporting PeproGMP products.
• Lead Cranbury Quality Control team and ensure lab operations.
• Maintain ISO 9001 certification, drive continuous improvement.
• Oversee investigations, CAPAs, deviations, and change controls.
• Collaborate with Operations, Regulatory Affairs, R&D and other teams to resolve quality issues.
• Support customer audits, Quality Agreements, and quality inquiries.
• Champion Practical Process Improvement (PPI) across Quality activities.

Skills

Quality leadership

GMP experience

Regulatory liaison

Quality Control

Data analysis

Risk management

Leadership

Education

Bachelor's degree in Science/Engineering/Biochemistry/Biotechnology

Advanced degree preferred

Job description

Thermo Fisher Scientific in Cranbury, NJ is seeking a seasoned Quality Manager to lead the Quality Assurance and Quality Control functions for PeproGMP products. You will drive compliance, investigations, CAPAs, and continuous improvement across manufacturing and laboratory operations.

The role partners with Operations, Regulatory Affairs, R&D, and cross-functional teams to resolve quality issues, steward ISO 9001 certification, and ensure data integrity and patient safety.