Principal Quality Auditor - Remote US

Overview

Responsibilities

This opportunity is with Syneos Health Consulting.  Your primary focus will be to conduct External GCP Audits.  You will work with some of the industries sharpest minds, and will enjoy flexibility to conduct your professional Pharmaceutical and Biotech Clinical Audits as the lead and primary auditor.  To be successful in this role, you will need to have extensive experience as the lead or primary auditor conducting external clinical trial audits, deep understanding of CRO auditing and excellent communication skills.

You will be joining an industry-leading consulting firm, Syneos Health,  specializing in the biopharmaceutical industry providing services across a comprehensive range of key Practice Areas including commercial strategy and planning, medical affairs, risk and program management and pricing and market access. You’ll join a team with industry focus, depth of functional expertise, and strong scientific and market knowledge that is uniquely positioned to tackle highly complex business and market challenges to develop successful commercial strategies for our clients.

Primary Responsibilities:

In this role, you will schedule, conduct and document assigned audits of projects in accordance with approved procedures, schedules and formats. Specific audit areas will include, but are not limited to: investigator sites, trial master and project management files, data management activities and files, safety reporting, final study reports, and vendors. More specifically:

• Lead for-cause audits to address suspected critical audit findings, fraud, or misconduct related to investigator sites, vendors, etc. These complex and highly sensitive audits may involve issues related regulatory violations, controlled substances, and other highly sensitive matters.
• Conduct audit debriefs with project teams and/or sponsor
• Writes and issue audit reports in accordance with standard company formats and timelines, ensuring clear communication of audit findings to the relevant project team members.
• Maintain accurate and timely documentation of QA auditing activities.
• Serve as a trainer and mentor to newly hired QA Auditors.
• Serve as Global Lead Auditor on projects as assigned.
• Maintain subject matter expertise through training (internal and external), review and/or preparation and presentation of papers, review of guidelines, and regulations, etc.
• Participate in Trusted Process meetings such as Kick-off, Quick Start Camp, and Quality Finish Camp.

Please note - This is a remote-based position (any US location) that will require up to 75% travel. 

Job Requirements

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities. Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:

• A Bachelor’s Degree in the science/health care field or equivalent combined education and experience
• Extensive experience in clinical quality assurance auditing (GCP)and conduct of vendor audits (e.g. of central laboratories, clinical suppliers, IRBs, etc.)
• Strong knowledge of all applicable Good Clinical Practice (GCP) regulations and guidelines.
• Knowledge of medical terminology preferred.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment.
• Strong organizational, presentation, documentation and interpersonal skills with diverse cultures.
• Ability to negotiate and provide constructive feedback.
• The ability to travel up to 75%

As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.
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