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Evotec

Global drug-discovery services via partnerships

Senior Quality Management Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timePrinceton, NJ, USA

About the Job

Requirements

  • A Master's degree or higher in Quality Management or a Life Sciences discipline with relevant focus, or equivalent relevant industrial or academic experience, is expected.
  • At least 3 years of work experience within a pharmaceutical, biotechnology, or contract research organization environment.
  • Good understanding of research activities and processes in Life Sciences.
  • Good knowledge of Good Laboratory Practice and Good Clinical Practice applied to bioanalytical activities, including biomarkers and LC-MC methodologies.
  • Ability to work in a team and matrix environment.
  • Ability to work with a high level of autonomy and be proactive.
  • Strong attention to detail and strong written and oral presentation standards.
  • Strong communication and networking skills, including remote interactions, as well as organizational and time management abilities and customer orientation.
  • Ability to work with a closely interacting team to deliver to tight timelines.
  • Ability to solve problems and adapt effectively in a fast-moving, high-growth environment.

Responsibilities

  • Oversee and support implementation and maintenance of Good Research Practice across scientific and discovery functions, particularly Protein Sciences, Chemistry, Sample Management, and ADME, ensuring proportionate quality oversight aligned with research activities and risks.
  • Support implementation and maintenance of Good Laboratory Practice and Good Clinical Practice 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 Good Research Practice, Good Laboratory Practice, Good Clinical Practice, and internal requirements using a risk-based approach.
  • Support sponsor audits and regulatory inspections, and 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 resulting from audits, inspections, monitoring activities, or investigations.
  • Foster a strong quality culture across the site and promote continuous improvement through communication, coaching, and training initiatives.
  • Collaborate with stakeholders and Quality representatives across global sites to support alignment, harmonization, and sharing of quality best practices.
  • Contribute to global quality objectives by supporting activities and initiatives across sites through 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 on Good Research Practice, Good Laboratory Practice, Good Clinical Practice, data integrity, good documentation practices, and risk-based quality principles.
  • Escalate significant quality risks, compliance concerns, and emerging trends to site and Quality leadership for timely awareness and decision-making.

About the Company

Evotec

Global drug-discovery services via partnerships

Evotec provides research and development services for drug discovery and development through strategic partnerships with pharma, biotech, and academic groups. Its work relies on proprietary platforms such as iPSC-derived cellular models and machine learning to run experiments and analyze data from early discovery through clinical development, often using patient-derived materials to support precision medicine. Unlike many competitors, Evotec offers an integrated, end-to-end R&D platform within collaborations, combining data-driven biology with cell- and gene-therapy capabilities rather than selling standalone tools. Its goal is to bring new and better medicines to patients faster and at lower cost by making the drug development process more efficient through partnerships.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Hamburg, Germany
Founded
1993

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