Principal QA Auditor GCP

Description

Principal QA Auditor

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. 

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• 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.

Job Responsibilities

Conduct audits to assess compliance with applicable regulations, company policies, standard operating procedures and (SOPs) work instructions (WI), contracts and project-specific requirements. Hosts and supports customer audits and regulatory inspections in accordance with QA SOPs and WIs.The Principal Quality Assurance (QA) Auditor is a seasoned professional who has significant expertise in GxP requirements and extensive experience in the conduct of various audit types. This role is therefore also responsible for other QA program initiatives such as mentoring of QA staff, training of operational staff, development and review of QA and regulatory standards and external engagement.

General ProfileSyneos Health AuditsPlans and conducts assigned audits.Performs For Cause audits as needed.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.Customer Audits/InspectionsPrepares for and hosts or supports customer audits.Prepares for and hosts or supports Regulatory Authority Inspections.OtherServes as Lead Auditor on team-based Syneos Health audits.Serves as a trainer and mentor to less experienced QA Auditors.Provides guidance and training to operational staff on quality related matters.Writes, reviews or revises QA SOPs/WIsComplexityApplies critical thinking to identify solutions to non-standard requests and complex problems.SupervisionRequires minimal instructions on day-to-day work and new assignments.Other tasksMay review audit reports of peers.May provide coaching and training to company personnel on quality-related matters.Participates in local and / or company-wide special projects according to his / her skills or talents and the needs of the organization.Involves himself / herself in appropriate industry associations and other relevant forums.Performs other work-related duties as assigned.Moderate travel may be required (up to 50%).

Qualifications

Requires a Bachelor’s degree in the science/health care field or equivalent with significant experience and expertise in various 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.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 and provide constructive feedback.Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation.

Get to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health