Syneos Health · 8 hours ago
Senior Auditor, Quality Assurance
United States
Full-time
Remote
Senior LevelSyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The Senior Auditor in Quality Assurance is responsible for planning and conducting audits, writing audit reports, and ensuring compliance with regulatory requirements, while also mentoring less experienced auditors.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Plans and conducts assigned audits
Performs For Cause audits
Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management
Reviews responses to audit findings for appropriateness and completeness
Closes assigned audits
Prepares for and hosts or supports customer audits
Prepares for and hosts or supports Regulatory Authority Inspections
Serves as Lead Auditor on team-based Syneos Health audits
Serves as a trainer and mentor to less experienced QA auditors
Requires minimal instructions on day-to-day work and new assignments
May write, review or revise QA Standard Operating Procedures (SOPs) / Work Instructions (WIs)
Performs other work-related duties as assigned
Moderate travel may be required (up to 50%)
Qualification
Required
Requires a Bachelor's degree in the science/health care field or equivalent with extensive experience in GxP quality assurance auditing
Excellent Knowledge of GxP regulatory requirements
Knowledge of Medical and technical terminology related to the audit types to be conducted
Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency)
Able to handle multiple tasks to meet timelines in dynamic environment
Strong organizational, presentation and interpersonal skills
Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds
Ability to negotiate, problem solve and provide constructive feedback
Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation
Preferred
Previous experience in the conduct of multiple audit types (e.g. vendors, investigator sites, trial master files, data management, safety reporting and laboratories) is preferred
Benefits
Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Total Self culture
Company
Syneos Health
Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
Founded in 1985
10001+ employees
H1B Sponsorship
Syneos Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (26)
2023 (49)
2022 (63)
2021 (84)
2020 (63)
Funding
Current Stage
Public CompanyTotal Funding
$524.65M2023-09-28Private Equity
2023-05-10Acquired
2021-03-01Post Ipo Secondary· $524.65M
Leadership Team
Costa Panagos
Chief Executive Officer
Michael Bonello
Executive Vice President and Chief Financial Officer
Recent News
2026-01-09
Company data provided by crunchbase