Senior Quality Leader: GRP/GLP/GCP, Site-Based

Cyprotex Limited; Princeton (NJ); Sur place; USD 94 000 - 127 000; Plein temps

Avantages offerts par ce poste

Discretionary annual bonus

Medical, Dental and Vision benefits

401k company match

Paid time off

Résumé du poste

Evotec in Princeton, NJ is seeking a Senior Quality Management Specialist who thrives on solving complex quality challenges. You will oversee GRP, GLP and GCP programs across discovery and bioanalytical functions, ensuring risk-based compliance and robust documentation practices.

You’ll lead internal audits, support sponsor inspections, drive CAPAs, and foster a culture of continuous improvement through training and cross-site collaboration.

Qualifications

• Master’s degree in Quality Management or Life Sciences, or equivalent experience.
• At least 3 years’ experience in Pharmaceutical, Biotechnology or CRO environment.
• Strong knowledge of GLP and GCP in bioanalytical activities including biomarkers and LC-MS methodologies.

Responsabilités

• Oversee GRP implementation across scientific functions with appropriate quality oversight.
• Support GLP and GCP frameworks for bioanalytical activities and provide guidance.
• Interpret regulatory requirements and communicate quality expectations across R&D.
• Maintain the documentation management system.
• Prepare and perform internal audits for GRP/GLP/GCP with risk-based approach.
• Support sponsor audits and regulatory inspections; facilitate CAPA implementation.
• Investigate quality events, deviations and sponsor complaints with root-cause analysis.
• Monitor CAPAs from audits/inspections and drive improvements.
• Foster a strong quality culture and cross-site quality collaboration.

Connaissances

Interpersonal skills

Communication skills

Teamwork

Autonomy

Formation

Master’s degree in Quality Management or Life Sciences

Description du poste

Evotec in Princeton, NJ is seeking a Senior Quality Management Specialist who thrives on solving complex quality challenges. You will oversee GRP, GLP and GCP programs across discovery and bioanalytical functions, ensuring risk-based compliance and robust documentation practices.

You’ll lead internal audits, support sponsor inspections, drive CAPAs, and foster a culture of continuous improvement through training and cross-site collaboration.