Associate Director, Regulatory Compliance
7 days ago
IQVIA Argentina is seeking an experienced Associate Director, Regulatory Compliance to join our RDS IT Compliance and Validation team. As a key member of our team, you will serve as the point of contact between IQVIA's sponsors or clients, internal IT product teams, and enterprise quality assurance teams. Your critical role will provide compliance insight, perspective, and input into Sponsor Engagement Plans and fulfillment strategy to meet IQVIA's compliance commitments.
About the Job:
- You will be responsible for ensuring technology deployment and IT process consistency across Sponsor/IQVIA partnership as an IT Compliance and Validation account lead.
- You will engage with key internal stakeholders to define the Sponsor Oversight on computerized Systems engagement plan and fulfillment strategy to meet IQVIA's compliance commitments.
- You will develop communications strategies in line with company's strategy to engage with key sponsors.
- You will outline validation methodologies and approaches for communicating expectations, decisions, risk/issues, and project progress information to sponsors.
- You will define and advise product teams on regulatory requirements and risks within the product life cycle based on regulatory guidance and global regulations.
- You will participate in system compliance assessments, categorization, and regulatory impact assessments, and computer system validations for developing technologies.
- You will support regulatory inspections and customer audits or qualifications consistent with corporate policy and position as determined by IQVIA's Quality Management System.
- You will represent IQVIA Quality Management in sponsor meetings and keep them informed on IQVIA's vision, goals, and products.
- You will effectively communicate sponsor needs to the IT team and follow through for successful closure.
- You will serve as an escalation point for any sponsor reported IT compliance and quality issues. Assist in the development of Compliance KPIs to track the effectiveness of partnership.
- You will drive teams to efficiently gather computerized system validation and associated materials. Assess the review of requested deliverables for accuracy and completeness.
- You will partner with QA to ensure IQVIA vendor process and deliverable compliance. Recommend actions to align with Sponsor requests.
- You will foster system lifecycle and validation process alignment with various internal product teams to comply with product quality.
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