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Senior Quality Specialist



Job Description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Due to an expanding portfolio, we have an exciting opportunity for an experienced Senior Quality Specialist to be based in Eastern Europe.

Candidates must have a strong knowledge of programming and able to document this in their CV and demonstrate it in an interview.

At Parexel, Quality Specialists act as a Quality partner for GDO Biostatistics and Statistical Programming, focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise through the execution of quality SOPs to support operations, leadership and clients

  • Manage the relationship with GDO Biostatistics and Statistical Programming

  • Provide Quality input to audits/inspections

  • Facilitate identification, investigation and remediation of Quality Issues (QIs) related to GDO Biostatistics and Statistical Programming activities

  • Facilitate the Risk Evaluation process

Knowledge and Experience:

  • Strong knowledge of programming and able to document this in their CV and demonstrate it in an interview.

  • Significant industry experience in one or more areas of PQRM support and / or Quality Management

  • Knowledge of ICH-GCP and clinical trial regulation

  • Experience using root cause methodologies (5-whys, fishbone diagram, etc.)

  • IT literate - experience with Microsoft based applications and functional and TMF applications / languages / solutions.

  • Able to embrace new technology and apply best practices

  • English proficiency (written and oral)


• Emerging ability to lead without explicit authority

• Self-management: independent, takes initiative, proactive and organized

• Focused on quality results - attention to detail and First Time Quality

• Interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback

• Ability to develop professional, collaborative relationships both within Quality and with Operations (and clients where assigned)

• Skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues

• Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge

• Cultural awareness with the ability to think and work, globally

• Ability to travel as needed for the position


• Bachelor’s Degree or other relevant experience required. Life-science, health or industry-related discipline preferred

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