Senior Quality Specialist

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