Manager, Clinical Quality Assurance - Bucharest

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

• Responsible for generating own and reviewing others' audit reports.
• Prepares for and hosts or supports customer audits in accordance with QA SOPs and WIs. Coordinates responses to customer audits of investigator sites, and resolves issues with customers, where applicable.
• Plans and provides strategies for assessing readiness of Syneos Health offices for potential Regulatory Inspections and conducts such assessments (e.g. develops a program for and conducts 'mock inspections'). Develops and delivers inspection readiness training to staff.
• Prepares for and hosts or supports Regulatory Authority Inspections in accordance with QA SOPs and WIs. Coordinates the preparations and activities for inspections by Regulatory Authorities, including compilation of any pre-inspection required information.
• Communicates findings from customer audits and Regulatory Authority Inspections of Syneos Health promptly to appropriate Syneos Health personnel and provides support on root cause analysis, corrective and preventive actions.
• Provides consultancy on quality related matters as needed.
• Builds and maintains an organization that meets the needs of Syneos Health and its customers and ensures that his / her direct reports deliver against the budget, timeline, and quality requirements.
• Supports the staff in project execution.

• Knowledge of Medical and technical terminology related to the audit types to be conducted.

• Anticipates and resolves key technical, operational, or business problems related to non-compliance with GxP.
• Applies critical thinking to identify solutions to non-standard requests and complex problems.
• Well versed in personnel management, customer management and project management.

• Requires a Bachelor's degree in a science/health care field or equivalent with significant experience and expertise in all aspects of GxP quality assurance auditing.
• Previous experience in the conduct of multiple audit types (e.g. vendors, investigator sites, trial master files, data management, safety reporting, and laboratories) is essential.
• Excellent knowledge of GxP regulatory requirements.
• Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency).
• Able to act independently and proactively.
• Above average attention to detail.
• Able to handle multiple tasks to meet timelines in a dynamic environment.
• Strong organizational, presentation and interpersonal skills.

Syneos Health