Senior Quality Specialist
South Africa, RemoteAdditional Locations: Romania-Remote; Job ID R0000033691 Category Quality Management
About this Role
Due to an expanding portfolio, we have an exciting opportunity for an experienced Senior Quality Specialist to be based in South Africa or Eastern Europe (selected countries). 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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