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Senior Quality Specialist

4 miesięcy temu

REMOTE, Polska Parexel Pełny etat

Due to an expanding portfolio, we have an exciting opportunity for an experienced Senior Quality Specialist to be based in Eastern Europe, South Africa, or South America (Brazil). Candidates must have a strong clinical trial background, solid Quality knowledge, at least high-level awareness of statistical programming, and must be able to document this in their CV and demonstrate it in an interview.

Within the open position, the Senior Quality Specialists will act as a Quality partner for 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

Act as a Partner in Quality for Biostatistics and Statistical Programming staff members Perform risk-focused evaluations to ensure that the highest quality standards of Biostatistics and Statistical Programming work are met Facilitate identification, investigation and remediation of Quality Issues (QIs) related to Biostatistics and Statistical Programming activities Provide Quality input to audits/inspections Participate in or drive initiatives for further quality improvement of Biostatistics and Statistical Programming work Manage the relationship with Biostatistics and Statistical Programming local management
​Knowledge and Experience: Significant experience in one or more areas of Quality Management within clinical trial industry Knowledge of ICH-GCP and clinical trial regulation At least high-level knowledge of statistical programming and statistical analysis principles Experience in Quality Issue management and root cause methodologies (5-whys, fishbone diagram, etc.) Preferably audit and regulatory inspection support experience IT literate - experience with Microsoft Office applications and functional and TMF applications / languages / solutions. Able to embrace new technology and apply best practices English proficiency (written and oral)
Skills: Focused on quality results - attention to detail and First Time Quality Self-management: independent, takes initiative, proactive and organized Excellent interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback Emerging ability to lead without explicit authority 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

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