QA Manager (Post-Marketing Pharmacovigilance)

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, functional support, issue & CAPA management, regulatory consultancy, management of data analytics and customer relationship interactions. These services ensure our clinical research and post marketing 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 Manager is a member of the Pharmacovigilance (PV) and Commercial QA team and will serve as a PV QA subject matter expert within IQVIA. The QA Manager is responsible for supporting IQVIA’s GxP and regulated activities relating to post marketing and clinical pharmacovigilance, Real World and medical devices. This includes supporting IQVIA’s PV Quality Management System (QMS) through risk assessments, internal audits and the deviation and CAPA management processes to ensure that projects, processes and deliverables are in compliance with regulatory requirements and industry best practices.

Summary of Responsibilities:

The QA Manager will support the following processes and activities:

• Risk-based PV audit planning, conduct and reporting
• CAPA oversight from internal audits
• Quality metrics for and reporting on PV QMS
• Continuous improvement of IQVIA’s PV processes and QMS
• Updates to client’s Pharmacovigilance System Master File (PSMF) relating to IQVIA’s quality system
• Client audits and inspections, and resulting CAPA responses
• Management and oversight of Quality Issues
• QA point of contact for client QA.
  

Required Education and Experience:

• Bachelor’s degree in a scientific or healthcare-related field or equivalent
• Three (3) to five (5) years prior relevant experience.
• Minimum two (2) years of post-marketing PV experience in Pharma or CRO setting.
  

Required Knowledge, Skills and abilities:

• Thorough understanding of Good Pharmacovigilance Practice (GVP) and other regulatory requirements applicable to post-marketing pharmacovigilance
• Previous PV Quality Assurance or Quality Management experience.
• Knowledge in the conduct of audits and inspections, and the development of corrective action plans
• Strong interpersonal skills and the ability to positively influence and guide others
• Excellent problem solving, risk analysis and negotiation skills
• Demonstrated ability to manage multiple responsibilities
  

Desirable Knowledge, Skills And Abilities (but Not Required)

• Knowledge and understanding of GCP requirements
• Knowledge and understanding of Medical Information requirements
• Knowledge and understanding of Medical Devices
• Experience of using an electronic Quality Management System (eQMS) and electronic Content Management tools
  

Travel:

• Up to 20% may be required
  

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