Manager, Quality Assurance and Regulatory Compliance

1w1 week ago

Syneos Health

Athens, GR · Full-time · €55,000 – €85,000

About this role

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators across the drug development and commercialization continuum, helping navigate complexity and accelerate progress. Our Clinical Solutions team applies deep expertise to understand customer needs.

The CCQM position oversees all CQM activities in the respective country/cluster under the Regional Director. It ensures patient safety, high quality data, and compliance with regulations. The role implements local/global processes, identifies improvement opportunities, and supports audits and inspections.

Collaborate with passionate problem solvers in Functional Service Provider partnerships or Full-Service environments. Innovate as a team to help customers achieve goals while being agile and driven to deliver. Work impacts those in need through quality-focused efforts.

Discover why 25,000 colleagues choose Syneos Health, with passion for developing people through career progression and training. Enjoy supportive line management, peer recognition, and total rewards. Build an inclusive culture driven to shape healthcare's future.

Requirements

Expertise in ICH-GCP and local regulations with impact assessment skills
Knowledge of quality-related local processes in pharmaceutical clinical research
Experience implementing and updating SOPs/Work Instructions
Ability to manage networks of Subject Matter Experts for process compliance
Skills in identifying and leading process improvement initiatives
Proficiency in supporting audits, inspections, and continuous quality improvements
Familiarity with coordinating training in GCP and regulatory compliance
Background in Quality Control oversight within clinical operations

Responsibilities

Oversee all CQM activities in the respective country/cluster
Implement local/global processes/procedures and update local SOPs/WIs
Serve as local expert for ICH-GCP and local regulations, including impact assessments
Manage local network of owners/SMEs for global/local processes
Identify process gaps/opportunities for improvement and escalate as needed
Lead continuous quality improvement activities at country/cluster level
Act as local training point of contact and coordinate training needs
Coordinate and oversee all Quality Control activities with country operations