Principal QA Auditor

Principle QA Auditor

Location: USA / Canada

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business but that doesn't mean we can't have fun whilst we do it.

With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry!

Are you one of them?

At ICON, we have an incredible opportunity for an expert Principle QA Auditor to join the team in the USA or Canada.

The Role

As Principle QA Auditor, you will lead QA contracted audits of clinical trial data and records in order to assure compliance with ICON or Sponsor SOPs, study protocols, Good Clinical Practice guidelines and relevant regulations across the America region.

This role will include up to 35% travel.

• Lead regular contracted audits and for cause audits of the ICON quality system in order to evaluate the quality system against the requirements, appropriate regulations and applicable guidelines.
• Review audit replies to Q&C. Follow up all outstanding replies and report issues to the relevant management for action
• Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented.
• Assist with the development of the project audit procedures and scheduling of work
• When appointed lead auditor, perform the duties assigned in an efficient and effective manner.
• Keep the person to whom the QA Auditor reports informed of any QA issues within the department that require attention.
• Verification of audit CAPA completion where required by procedure.
• Ability to apply general knowledge of business developed through education or past experience.
• Good understanding of drug development and clinical trial process.
• Ability to review and evaluate clinical data/records/systems/processes
• Knowledge and experience in performing and leading Root Cause Analysis
• Well-developed interpersonal and communication skills (oral and written) with prior experience conducting presentations or facilitating meetings.

What you need

• 5+ years' experience working in QA
• GCP auditing experience is essential for this role.
• A great team player with a natural flair for collaborating with internal and external stakeholders.
• Solutions focussed with the ability to solve problems before they become an issue.
• Competent computer skills including Microsoft Word, Excel, PowerPoint and Outlook
• Good planning and organizational skills.
• Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Driver's license.

Why join us?

Other than working with an outstanding team of ambitious people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

Ongoing development is vital to us, and as a Principle QA Auditor, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/colour/religion/sex/sexual orientation/gender identity/disability/vet/national origin