Job Title: Senior Quality Management Specialist

Location: Site Based, Princeton, NJ

Shifts: Days, Monday to Friday

The Role: / your challenge, ...in our journey

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.

What You'll Do:

• 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 leadership, ensuring timely awareness and decision-making.

Who You Are:

• Master's degree (or higher/equivalent) in either Quality Management or Life Sciences discipline with relevant focus or equivalent relevant industrial or academic experience is expected.
• At least 3 years' work experience within a Pharmaceutical, Biotechnology or CRO environment.
• Good understanding of Research activities and processes in Life Sciences.
• Good knowledge of GLP and GCP (applied to bioanalytical analytical activities including biomarkers and LC-MC methodologies).
• Excellent interpersonal skills and the ability to work as a team and in a matrix environment.
• Comfortable working with high level of autonomy, highly proactive and enthusiastic.
• Strong attention to detail and excellent standards written and oral presentation skills.
• Strong communication and networking skills including remote interactions, as well as good organizational and time management abilities and customer orientation.
• Ability to work with a closely interacting team to deliver to tight timelines.
• Problem-solver, highly adaptive and able to work effectively in a fast moving and high growth environment.

Why Join Us:

• Growth Opportunities: We're a company that believes in continuous learning and development. Whether it's professional courses, mentorship, or new projects, we'll help you grow.
• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. This is a site based role.
• Inclusive Culture: We're committed to building a diverse and inclusive environment where everyone's voice is valued, and curiosity is encouraged.
• Innovative Projects: You'll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
• A Place for Big Ideas: We don't just talk about thinking outside the box-we throw the box away. If you've got ideas, we want to hear them.

The base pay range for this position at commencement of employment is expected to be $93,500 to $126,500. This is a salaried exempt position. Base salary offered may vary depending on the individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, generous paid time off and paid holiday, wellness and transportation benefits.