Principal Professional Quality Risk Manager (GCP Clinical Experience Required)
Responsibilities
- Provides support, consultancy and oversight on Quality Issues that occur across the organization during the performance of the services provided by both Clinical and Corporate.
- Leads root cause analyses and the implementation of corrective actions required to meet regulatory requirements.
- Participates in meetings with clients on the management of quality issues on their projects.
- Investigates QI‑related quality trends, potential risks and mitigations with QI Management.
- Contributes to or leads QI management process improvement initiatives, as assigned.
- Presents information to QI Management leadership, as applicable.
- Initiates and manages QI‑related quality trends, potential risks and mitigations with QI Management on an as‑needed basis.
- Travels as required (approximately 15%).
- Does not supervise employees.
Qualifications
- Comprehensive business and technical knowledge/experience to improve management of QIs at Syneos Health.
- Ensures commitments and timelines for QI management adhere to Syneos Health requirements.
- Provides solutions to QI management issues and identifies process improvement opportunities.
- Advises QA auditors and operational staff in providing QI information to sponsors, auditors, regulatory inspectors or other external parties.
- Reviews controlled documents, providing input on content alignment with Syneos Health controlled document standards and technical content.
- May be assigned to support quality‐related activities at an account/project level.
- Escalates issues to Corporate Quality leadership when required.
- Makes decisions that impact a range of standard and non‑standard operational, process, project, or service activities.
- Serves as a key resource to manage QIs and gains support for ideas or positions on difficult issues.
- Anticipates and resolves complex problems, applying strategic and critical thinking to identify solutions to non‑standard requests and moderately complex problems.
- Drives solutions for products, processes, and services across a large business area.
- Establishes key relationships with those outside of the business area.
- Assesses and interprets customer’s (internal and external) quality needs and requirements and proactively develops solutions.
- Leads medium‑scale or large QI Management or Corporate Quality projects or programs with moderate risks and resources.
Equal Opportunity Statement
We are 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. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
📌 Principal Professional Quality Risk Manager (GCP Clinical Exp Required) (Buenos Aires)
🏢 7257 Syneos Health Argentina
📍 Buenos Aires
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