An amazing opportunity has arisen for a Quality Lead Auditor. This role delivers the internal audit program and inspection readiness activities for areas within the remit of the company’s manufacturing Quality organization at Dunboyne Biologics. The role ensures that compliance team objectives are effectively achieved, consistent with the site’s requirements to ensure compliance, safety, and reliable supply to our customers.
Tasks and responsibilities include but are not limited to.
- Review execution of analytical method validations and transfers (among different sites, and between the Company and CROs) and write technical protocols and reports.
- Drive implementation of the site internal audit program.
- Drive 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 follows cGMP and the associated regulatory requirements.
- Ensuring 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 innovative, 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 and have a passion for continuous development and education.
- Expert level of knowledge of cGMP and Quality System regulations as they pertain to the site.
- Ten percent travel required.
- Top of Form
Your profile
- Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline.
- 10 years experience in the Pharmaceutical or Biological industry.
- 2 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, tracking to schedules, and embracing an interdependent work culture.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
