Lead External Quality Auditor

About the Company

My client are a Global Healthcare group with manufacturing operations worldwide and a commercial office in Dublin. Their portfolio includes a range of products across Medical Devices, Pharmaceuticals and Biologics.

About the Position

Reporting to the Senior Manager, the Lead Auditor (GMP Quality Compliance) will organise and perform quality audits across my clients network including suppliers/vendors, third parties, and internal manufacturing sites. The role is Permanent and positioned at Lead / Manager level (no direct reports). Working as part of the Global Quality team there is 40-50% travel involved (within EU and 1-2 Global trips per annum).

Key Responsibilities 

The Lead External Auditor will be responsible for the following:

• To manage the auditing program
• Perform evaluations of quality systems and practices
• Support the audit program by independently conducting internal & external audits
• Contribute to the development of the annual audit schedule
• Collect, collate and evaluate applicable key auditing performance parameters for metrics report generation and presentation to management and stakeholders
• Quality Auditing Department Support - responsible for the development and implementation programs, policies, procedures, agreements & controls

Experience/Requirements

• A BSc / MSc in Science, Engineering or related
• 10 years industry experience within the Pharmaceutical / Biotechnology space within Compliance or Quality Assurance
• Auditing experience and technical expertise across a variety of sites (GMP / GDP / GLP)
• Excellent communication and presentation skills - fluent English speaker
• Strong influencing skills, highly organised and action-oriented
• Strong interpersonal and coordination skills
• Eligible to live and work in Ireland
• Ability to travel 45 - 50% per annum

Remuneration Package

Competitive base salary - DOE.

Full benefits package including Bonus 15%, Pension, Healthcare.

Contact

For more information on this role or any other Life Sciences roles contact Gillian McMurrough via email or click on the apply button below.