Quality Product Lead: GMP QA & Client Collaboration

ThermoFisher Scientific; Plainville (MA); On-site; USD 104,000 - 156,000; Full time

Benefits offered by this job

Healthcare

Annual bonus

Stock purchase plan

Job summary

Thermo Fisher Scientific is seeking a Quality Product Lead to provide technical leadership for GMP manufacturing environments, ensuring quality, compliance, and continuous improvement.

In this role, you’ll partner with customers from batch startup through disposition, manage investigations and CAPAs, and help drive regulatory readiness while maintaining data integrity and strong documentation practices.

Qualifications

• Advanced degree plus 4+ years in GMP QA environment.
• Bachelor's degree plus 6+ years in GMP QA environment.
• Industry experience in pharma/biotech is required.
• Certifications such as ASQ CQE/CQA are valued.
• Experience with risk assessment methodologies and root cause analysis.
• Experience hosting regulatory inspections or audits.

Responsibilities

• Conduct risk assessments, lead investigations, manage CAPAs, and ensure regulatory compliance.
• Serve as a key QA representative to customers from batch startup through disposition.
• Communicate quality events, deviations, investigations, and product impact assessments.
• Build strong customer relationships while ensuring quality and compliance expectations.
• Contribute to robust quality systems and continuous improvement initiatives.

Skills

Quality assurance

GMP regulations

Regulatory inspections

Risk assessment

Root cause analysis

Documentation

Project management

Cross-functional collaboration

Data integrity

English fluency

Education

Advanced degree or equivalent

Bachelor's degree in a related field

ASQ CQE / CQA certification

Tools

QMS software

Document control systems

Job description

Thermo Fisher Scientific is seeking a Quality Product Lead to provide technical leadership for GMP manufacturing environments, ensuring quality, compliance, and continuous improvement.

In this role, you’ll partner with customers from batch startup through disposition, manage investigations and CAPAs, and help drive regulatory readiness while maintaining data integrity and strong documentation practices.