Senior Quality Management Lead GLP/GCP & R&D Compliance

Just - Evotec Biologics; New Jersey; On-site; USD 94,000 - 127,000; Full time

Benefits offered by this job

Growth Opportunities

Flexible Work Environment

Inclusive Culture

Innovative Projects

Big Ideas

Job summary

Evotec is seeking a Senior Quality Management Specialist for a site-based role in Princeton, NJ. You will drive GRP, GLP, and GCP quality oversight across discovery and development activities, maintain documentation systems, and coordinate audits and CAPA processes.

The role requires a Master’s in Quality Management or Life Sciences and at least 3 years in pharma/biotech/CRO environments, plus strong communication and regulatory knowledge to support cross-functional teams.

Qualifications

• Master’s degree in Quality Management or Life Sciences.
• At least 3 years’ experience in Pharmaceutical/Biotechnology/CRO environments.
• Strong knowledge of GLP and GCP in bioanalytical activities.

Responsibilities

• Oversee and maintain GRP across research functions with quality oversight.
• Support GLP and GCP implementation for bioanalytical activities.
• Interpret regulatory requirements and communicate them across RD teams.
• Maintain documentation management systems and quality records.
• Lead internal audits and support sponsor audits and inspections.
• Investigate quality events and track CAPAs to closure.
• Foster quality culture and cross-site quality alignment.

Skills

Quality management

Life sciences

Regulatory knowledge

GxP knowledge

Communication

Education

Master's degree in Quality Management or Life Sciences

Tools

GRP framework

GLP framework

GCP framework

Job description

Evotec is seeking a Senior Quality Management Specialist for a site-based role in Princeton, NJ. You will drive GRP, GLP, and GCP quality oversight across discovery and development activities, maintain documentation systems, and coordinate audits and CAPA processes.

The role requires a Master’s in Quality Management or Life Sciences and at least 3 years in pharma/biotech/CRO environments, plus strong communication and regulatory knowledge to support cross-functional teams.