Senior Quality Management Specialist, Site , Princeton, NJ

Job Title: Senior Quality Management Specialist

Location: Site Based, Princeton, NJ

Shifts: Days, Monday to Friday

At Evotec
, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #Be Cureious with us and see where your curiosity can take you!

We’re looking for a passionate and curious Senior Quality Management Specialist to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

As a Senior Quality Management Specialist at Evotec
, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.

• Oversee and support the implementation and maintenance of Good Research Practice (GRP) across scientific and discovery functions, particularly Protein Sciences, Chemistry, Sample Management, and ADME, ensuring appropriate and proportionate quality oversight aligned with the nature and risks of research activities.
• Support the implementation and maintenance of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) frameworks for bioanalytical activities (including biomarkers and LC-MC methodologies), as applicable, and provide quality oversight and guidance.
• Interpret and communicate applicable regulatory requirements, industry standards, and internal quality expectations, ensuring appropriate implementation across research and development activities.
• Maintain the documentation management system.
• Manage and maintain quality documentation, including policies, procedures, records, and controlled documents, in accordance with company requirements.
• Prepare, coordinate, and perform internal audits to assess compliance with GRP, GLP, GCP, and internal requirements applying a risk-based approach.
• Support sponsor audits and regulatory inspections; facilitate timely implementation of corrective actions.
• Facilitate investigations of quality events, deviations, non-conformances, and Sponsor complaints, ensuring appropriate root cause analysis and documentation.
• Monitor Corrective and Preventive Actions (CAPAs) resulting from audits, inspections, monitoring activities, or investigations.
• Foster a strong quality culture across the site and promote continuous improvement through effective communication, coaching, and training initiatives.
• Support and collaborate with stakeholders and Quality representatives across global sites, supporting alignment, harmonization, and the sharing of quality best practices throughout the organization.

• Contribute to global quality objectives by supporting activities and initiatives across various sites, requiring effective cross-site collaboration and stakeholder engagement.
• Monitor, analyze, and communicate quality metrics and key performance indicators; identify trends and drive improvement initiatives.
• Provide quality support and training to operational teams to strengthen understanding of GRP, GLP, GCP, data integrity, good documentation practices, and risk-based quality principles. Escalate significant quality risks, compliance concerns, and emerging trends to site and Quality…