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