MSD Site Lead Auditor 

Ireland 

116167245

Job Description

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• Lead implementation of the site internal audit program.
• Lead the implementation of the site inspection readiness program to ensure site permanent inspection readiness.
• Responsible for ensuring that the process for the manufacture of Biologics is in compliance with cGMP and the associated regulatory requirements.
• Responsible for ensuring that there is an effective Quality Management System is in place.
• Be an advocate of continuous improvement in the Quality Management Systems.
• Drive compliance direction by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.
• Lead proactive evaluation of site compliance against emerging regulatory trends.
• Ensure that quality issues are identified, addressed and resolved.
• Maintain Quality related metrics related to the Site Internal Audit program, ensuring effective communication and follow up of same.
• Represent the Quality Management System as appropriate during GMP inspections.
• Lead and perform internal audits (facility, system and walkthrough) in addition to management of the internal audit schedule at the site.
• Maintain current technical, compliance, regulatory, and audit skill knowledge to ensure audit program effectiveness through identification of early compliance warning signals.
• Perform audits at regional sites, and host regional guest auditors (as applicable). Lead by example and apply cutting edge, risk-based audit techniques.
• Effectively communicate audit/inspection results to stakeholders and site leaders. Evaluate root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for audits & inspections for complete remediation.
• Support the preparation and hosting of Health Authority inspections and Divisional GMP Audits.
• Generate and report metrics / trends for program adherence to requirements and effectiveness.
• The motivation to be an inspiring member of a high performing team.
• Communication, decision making, people influencing and project management skills.
• Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues.
• Ambition and drive to develop and advance their career within the company and have a passion for continuous development and education.
• Seasoned leader with the expertise and leadership (team leader expertise) attributes that will ensure success in this highly responsible role.
• Expert level of knowledge of cGMP and Quality System regulations as they pertain to the site.
• 10% travel required.

What skills you will need:

• Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline.
• 12 years experience in the Pharmaceutical or Biological industry.
• 4 years experience in delivering Site Internal Audit programs and Inspection Readiness programs in a regulated environment.
• GMP Audit experience in the Pharmaceutical industry.
• Proven record of accomplishments of working in a Pharma/Biopharma company or related industry is desirable.
• Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture.
• Experience working in a GMP/regulated environment is desirable.
• Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.

So, if you are ready to:

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.