Job Summary:
The Associate Director of Quality Assurance at IQVIA serves as a key quality and compliance contact within the assigned portfolio. This role will be part of the Real World Solutions Quality Management team and would involve supporting quality meetings, assisting in investigations & issues, contributing to quality improvement initiatives, and ensuring compliance with regulatory requirements. The individual will also participate in risk management efforts and provide guidance on quality management processes across the portfolio.
Associate Director, Quality Assurance Job Responsibilities:
- Serve as an SME/ point of contact within Quality and Compliance for triage, evaluation, and routing of all Quality topics pertinent to the supported portfolio.
- Manage and support Quality meetings at all levels of the portfolio, including QA meetings, Joint Operating meetings, Operational Management Meetings, Executive Oversight Committees, and Steering Committees.
- Provide routine QA metric reporting from the IQVIA Quality Management system, including Quality Issues, Corrective and Preventative Actions, Audits, Inspections, Investigations, and Serious Breaches.
- Support Quality Issues, Investigations, Serious Breaches (Major & Critical issues), escalations, audits, and inspections impacting the assigned client portfolio.
- Offer Quality consultation and guidance to IQVIA portfolio teams during routine activities and communicate outcomes and directives from client Quality meetings to IQVIA portfolio operational management.
- Assist in risk identification and mitigation activities related to portfolio operations and activities, and support portfolio and team Quality initiatives and improvement activities.
- Lead team improvement initiatives and support team leadership in furthering the service, while recognizing, exemplifying, and adhering to IQVIA's values.
- Lead, develop, grow, and manage the Quality Management team, ensuring an effective management structure is in place.
- Ensure that IQVIA QMS procedures are updated to comply with changes in laws, standards, and regulations to accommodate process improvements and business needs.
- Serve as the RWS expert on Quality-related matters and provide periodic reports on defined key quality indicators to business operations and upper management.
- Maintain a current knowledge base through internal and/or external training and participate in professional development through journal articles and by presenting at and attending conferences and professional meetings.
- Provide input and support to operational teams on issue resolution and process improvement and offer input into Global Quality & Compliance Leadership for strategic direction.
- Meet internal and external customers when necessary and undertake other related duties as assigned.
- Ensure compliance with all applicable regulatory requirements and standards, develop, and implement regulatory compliance strategies and policies, and monitor changes in regulatory requirements.
- Conduct internal audits to ensure adherence to regulatory standards, consult with internal regulatory experts, and represent the organization during inspections and audits.
- Provide training and guidance to staff on regulatory compliance matters, foster a culture of continuous improvement and professional development within the team, and identify and address training needs to enhance team skills and performance.
- Mentor and coach team members to support their career growth and development, facilitate team-building activities, and conduct regular performance reviews with constructive feedback.
- Develop and implement risk management strategies to identify, assess, and mitigate potential risks, and monitor and evaluate risk factors that could impact the quality and compliance of the portfolio.
- Perform risk assessments, create contingency plans, and work with cross-functional teams to incorporate risk management practices into all areas of the portfolio.
- Develop and implement continuous improvement strategies to enhance quality and efficiency, monitor and analyze quality performance metrics, and lead continuous improvement projects and initiatives.
- Encourage a culture of innovation and continuous improvement within the team and provide training and support to staff on continuous improvement methodologies and tools.
- Lead, support and/or sponsor strategic initiatives by utilizing industry standard Project/Program management methodologies
Required Expertise:
- Strong knowledge of Good Clinical Practice (GCP) guidelines.a
- Familiarity with ISO standards, particularly ISO 9001 (Quality Management Systems) and ISO 13485 (Medical Devices).
- Experience with regulatory compliance and quality management systems (QMS).
- Proficiency in risk managemeant and continuous improvement methodologies.
- Excellent leadership and team management skills.
- Strong analytical and problem-solving abilities.
- Effective communication and interpersonal skills.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.
