Senior Compliance Auditor (Home Based)

This innovator is a global pharmaceutical company focused on developing first-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. With offices and facilities in the US, South America, Asia and Europe (Ireland) and over 3000 employees globally and circa 400 in Ireland, this organisation has seen steady expansion here in Ireland in the last 3 years across both sites and virtual operations. As a result of further expansion, a new position has arisen for a Global Senior Compliance Auditor. This position can be based in their facilities in Dublin or Cork, with also the opportunity to work remotely.

The primary responsibility of the position is the planning and execution of audits to assess ongoing compliance with government regulations and corporate standards of the organisations suppliers and internal sites. As the Senior Compliance Auditor you will play a key role in executing the companies GMP compliance program.

Responsibilities:

  • Prepare and lead GMP audits across multiple internal sites and third parties both domestic and international. – Domestic and International travel required (50%)
  • Identify compliance risks and develop sound rational for observations against current regulatory requirements and standards
  • Provide timely audit reports, timely data entry into the data tracking systems and evaluate corrective action plans
  • Assist in the development and training of audit team members

Person:

  • The ideal candidate will have 8 – 12 years of experience in pharmaceutical, biotech or medical device industry
  • 7+ years compliance auditing experience
  • Knowledge of GMP and GDP regulations (US, EU and Japan) and related guides and standards
  • Demonstrated lead auditor skills

To discover more about this opportunity, apply now or contact Ciara O’Brien at HRM on +353 1 632 18 55 for a confidential discussion.

Salary: On Application Location: Nationwide