Principal Professional Quality Risk Management

Principal Professional Quality Risk Management (GCP Clinical Exp Required)

Job Responsibilities

• Provide support, consultancy, and oversight on Quality Issues that occur across the organization during the performance of services provided by both Clinical and Corporate.
• Lead root‑cause analyses and implement corrective actions to meet regulatory requirements.
• Participate in client meetings on the management of quality issues on their projects.
• Investigate QI‑related quality trends, potential risks, and mitigations with QI management.
• Contribute to or lead QI management process‑improvement initiatives, as assigned.
• Present information to QI management leadership, as applicable.

Functional and Technical Expertise

• Maintain comprehensive business and technical knowledge to improve QI management.
• Ensure QI‑management commitments and timelines meet Syneos Health requirements.
• Offer solutions to QI‑management issues and identify process‑improvement opportunities.
• Advise QA auditors and operational staff in providing QI information to sponsors, auditors, regulatory inspectors, or other external parties.
• Review controlled documents, ensuring alignment with controlled‑document standards and providing technical content input.
• May support quality‑related activities at the account/project level.

Complexity & Decision Making

• Resolve complex problems and conduct complex analyses.
• Translate concepts into practice.
• Escalate issues to Corporate Quality leadership when required.
• Make decisions that impact a range of standard and non‑standard operational, process, project, or service activities.

Influence & Leadership

• Serve as a key resource to manage QIs and gain support for ideas or positions on difficult issues.

Problem Solving & Impact

• Anticipate and resolve complex problems using strategic and critical thinking.
• Drive solutions for products, processes, and services across a large business area.
• Establish key relationships with internal and external customers, assess and interpret quality needs, and proactively develop solutions.

Project Management & Supervision

• Lead medium‑scale, or occasionally large QI management or Corporate Quality projects or programs with moderate risks and resource needs.
• Receive little day‑to‑day instruction; general instructions on new assignments suffice.
• Represent QI management as assigned and perform other quality‑related activities directed by management.

Travel

Travel may be required (approximately 15%).

Equal Employment Opportunity

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Further, nothing contained herein should be construed to create an employment contract.