Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
A QA Manager is responsible for Collaborating with Quality counterparts at customers and with internal project teams to proactively promote, support and facilitate proactive quality through the identification and management of risks and implementation of quality improvement activities.
Summary of Responsibilities:
- Provides actionable insights from quality and operational data analysis and proactively working with the customer and the account team to develop action plans to drive continuous improvement.
- Analyzes trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams
- Supports the management and resolution of significant issues relating to quality;
- In collaboration with Quality Management, ensures projects are inspection ready starting at the design stage.
- Drives inspection readiness activities for the customer, including contributing to mock inspections by/of the customer
- Contributes to the development of the global risk-based internal audit plan.
- Advises customer Quality counterparts on the strategy for regulatory inspections and collaborates in the preparation for and management of inspections at customer offices and, as necessary, at investigator sites.
- Prepares for and actively participates in relevant Governance/partnership level meetings e.g. Quality Councils/ Joint Operations Committee (JOC) or equivalent meetings with customer Quality counterparts.
- Interfaces with senior management to discuss quality and compliance issues
- Interfaces with business development and operations to identify business opportunities
- Hosts and/or supports customer audits and ensures appropriate and sustainable action plans are developed and implemented.
Required Knowledge, Skills and abilities:
- Thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws and guidance.
- Practical experience in conducting internal process, site and vendor audits
- Practical experience applying proactive quality approaches for clinical trials.
- Working knowledge of real world evidence and non-interventional studies preferred.
Required Education and Experience:
- Bachelors degree in a scientific or healthcare-related field
- Demonstrated experience leading and successfully delivering on GCP audits
- Minimum 5 years of experience in clinical quality in a pharmaceutical, biotech, or other regulated industry.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™
Job ID: R1070055