QA Director (PV Inspections - Clinical Trails)

Jobinhalt

Remote Opportunity

Summary:

The IQVIA QA team is a dynamic, talented, and experienced global team that owns the global quality management system for the largest human data science company in the world. The QA function is responsible for driving compliance in a highly regulated industry through audits, hosting customer audit and regulatory inspections, functional support, issue & CAPA management, regulatory consultancy, management of data analytics and customer relationship interactions. These services ensure our clinical research activities are of the highest quality. We proactively support our business partners and help to drive innovation. Continuous improvement is a core capability, and we value strategic thinking, creativity and operational excellence. We seek highly motivated people who truly want to make a difference in the life sciences industry and are looking for opportunities to impact the business and be part of the solution. At IQVIA, we support our colleagues with a focus on succession planning, career progression and continuous learning.

Purpose:

The QA Director in the Customer Audit & Regulatory Inspections team will drive the respective quality assurance programs at a regional and/or global level. Provide direction in support of customer / functional accounts, audit and inspection programs, and the QA quality management systems. Provide insights, analyses and support in the promotion and assessment of compliance with regulations, guidelines, and operating procedures within the Region or Globally Assigned. Guidelines and corporate policies.

Summary of Responsibilities:

• Coordinate and lead the management of regulatory inspections in the region, including the scheduling, planning, and hosting of regulatory inspections, and participation in the review of corrective and preventative action plans and effectiveness checks.
• Ensure proper coordination of customer-initiated audits and mock regulatory inspections, as required.
• Collaborates with Quality counterparts at customers and with internal project teams to promote, support and facilitate proactive quality through the identification and management of risks and implementation of quality improvement activities.
• Establish and maintain strong working relationships with internal and/or external customer team leads and counterparts, as assigned.
• Provide actionable insights to customer counterparts, QA Leadership and Senior Management.
• Drive quality improvements and efficiencies along with risk mitigation based on QA data analyses, operational performance data, knowledge of process management, changing regulations and customer expectations.
• Provide consultation and support concerning compliance with regulations and appropriate controls, quality measures and risk assessment and mitigation in the development of improved or new service offerings across the business.
• Lead and project manage internal QA quality improvement initiatives.
• Plan, schedule, conduct, report and close audit activities.
• Assist in enhancement and establishment of quality assurance and control policy and risk identification and mitigation by providing consultation and recommendations to regional and Global QA Leadership.
• Serve as author for QA Standard Operating Procedures (SOPs).
• Serve as QA representative on Standard Operating Procedures (SOP) Taskforce(s) for other IQVIA functional areas as assigned.
• Participate in or lead teams for special projects as assigned. Teams may be cross functional.
• Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.
• Recommend process and systems for audit, write systems audit plans and oversee the delivery of these audits, review the Corrective and preventive actions (CAPAs) and ensure appropriate follow up.
• Oversee documentation, reporting, and closure of significant compliance issues.
• Support QA Management Leadership in proposal reviews and reporting QA metrics and insights
• Act as primary back-up for the Head of CARI.
• Conduct trend analysis of inspection and audit results and provide QA management with initial root cause analysis.
• May present trend analysis results and QA metrics and insights to IQVIA upper management.
• If required, manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.
  

Required Education and Experience:

• Bachelor and Master’s degree in a scientific or healthcare-related field.
• Demonstrated experience scheduling, planning and hosting regulatory inspections.
• 12 years of Quality Assurance experience in pharmaceutical, technical, or related area
• 7 years of GCP and PV Quality Assurance experience
• 5 years of Management experience
• Equivalent combination of education, training, and experience.
  

Required Knowledge, Skills, and abilities:

• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• Extensive knowledge in hosting GCP and PV regulatory inspections, including in front and back-room roles.
• Preferred experience in GCP, PV and other GxP auditing.
• Thorough understanding of GCP, GVP (optional), and other relevant quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws and guidance.
• Preferred experience in Real Word Data / Real World Evidence, Computer System Validation and Customer Audit Hosting.
• Senior Management experience in Quality Assurance.
• Strong training capabilities.
• Ability to manage costs effectively through appropriate resource allocation.
• Knowledge of word-processing, spreadsheet, and database applications.
• Knowledge of quality assurance processes and procedures.
• Strong interpersonal skills.
• Excellent problem solving, risk analysis and negotiation skills
• Effective organization, communication, and team orientation skills.
• Ability to initiate assigned tasks and to work independently.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Ability to influence and guide others at all levels of management.
• Demonstrated ability to lead and manage multiple responsibilities and projects.
• Ability to articulate and define departmental needs and processes.
  

Travel:

• Up to 20-40%
  

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