The candidate will serve as a Quality Specialist for the Clinical Data Science (CDS) organization. The Quality Specialist is responsible for assessing and improving quality across the trial portfolio, working to implement best practices to ensure appropriate controls for Good Clinical Practice (GCP) during the implementation of new or updated systems and/or processes.
The role will focus on the development of a Quality Control Management Plan and implementation of a risk-based Quality Control (QC) process within CDS and Clinical Data Management (CDM) to perform quality review of study documents that are high risk to clinical trial quality and evaluate critical processes and procedures to identify any Sponsor's process gaps and/or procedural improvement opportunities. The successful candidate will manage, develop, and build an effective QC process and its capabilities with the goal of supporting a quality-oriented approach company wide. Through collaborative relationships with Bridge Quality, the candidate will support continuous quality process improvement through assessment of internal QC outcomes, internal audits and inspections.

Responsibilities:

• Develop, implement and manage a risk-based QC process of CDS/CDM activities
• Manage internal QC activities including scheduling, planning, and conducting the QC, and writing QC findings. Collaborate with study subject matter experts to review QC findings, provide guidance on remediation, and following-up on post-QC activities 
• Partner with Bridge Quality and CDS/CDM Therapeutic Area Heads to prioritize known compliance issues and identify critical processes, procedures and studies 
• Review key study documents, workflows and outputs to ensure studies are conducted in compliance with Sponsor's internal procedures, GCP and applicable global regulations 
• Evaluate responses to QC findings, verify evidence documents and ensure timely and accurate resolution 
• Communicate internal QC outcomes to Bridge Quality and CDS/CDM Therapeutic Area Heads, summarizing the QC activities, findings and mitigation activities
• Develop and manage comprehensive QC metric reports and analyze trends to identify process gaps, improvement opportunities and areas requiring corrective/preventive actions
• Support regulatory changes to evaluate compliance risks and provide guidance to CDS/CDM team based on interpretation of current regulations

Knowledge, Experience & Skills:

• 5 years of experience working in a clinical compliance, Quality Management function, or Clinical Functional Area with expertise and/or transferable skills in Good Clinical Practice and Regulatory Inspections
• Strong knowledge of GCP ICH and understanding of current regulatory requirements (FDA, EMA, MHRA, etc.) applicable to the conduct of clinical trials
• Excellent customer service, project management skills, and ability to take initiative and prioritize tasks to meet deadlines and produce results
• Excellent oral and written communication skills; effectively communicate with all levels of organization; good presentation and training skills
• Ability to multitask and prioritize handling a wide range of small, medium and long-term assignments in parallel and dealing with urgent issues as they arise in accordance with assigned deadlines 
• Ability to analyze trends and determine strategic improvement needs; ability to execute and monitor the implementation of quality improvement processes
• Self-motivated with the ability to work and collaborate effectively in a dynamic environment

Preferred skills:

• Relevant experience in the global pharmaceutical industry in functions such as Data Management, Statistics, or Clinical Operations, with at least 5 years of experience in GCP Quality/Compliance
• Advanced knowledge of pharmaceutical development and GCP regulations including FDA, EU, MHRA, PMDA and ICH
• Experience leading Audit and/or Regulatory Inspections 
• Extensive experience in leading GCP Quality & Compliance in the global pharmaceutical industry 

Education:

• Minimum of 6 years of experience in GCP Quality Assurance/Regulatory Compliance management and a bachelor’s degree in a scientific discipline 
• Minimum of 4 years of experience in GCP Quality Assurance/Regulatory Compliance management and a master’s degree in a scientific discipline

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $108,500.00 - $162,750.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.