Job Description

Principal Auditor - *GCP experience required

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.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.

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

*Please apply for this role with a CV in English.

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 Profile

• Syneos Health Audits
  • Plans 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/Inspections
  • Prepares for and hosts or supports customer audits.
  • Prepares for and hosts or supports Regulatory Authority Inspections.
• Other
  • Serves 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/WIs

Complexity

• Applies critical thinking to identify solutions to non-standard requests and complex problems.

Supervision

• Requires minimal instructions on day-to-day work and new assignments.

Other tasks

• May 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.

Requirements

• A minimum 5 years experience within GCP (Phase I-IV Clinical Trials) required
• 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.
• 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.

Get to know Syneos Health

Over 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.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. 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. The Company is 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.