Global Quality Auditing Outsourcing R&D Lead
The ‘Global Quality Auditing Outsourcing R&D Lead’ implements a Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) audit strategy, including delivery of a risk-based audit program covering the quality and compliance of the GCP/GLP Quality Systems. The incumbent ensures that clinical trials are managed in compliance with regulatory requirements, contractual agreements, and the company’s Global Quality Management System; and that compliance risks are appropriately identified and mitigated.
The Responsibilities
1. Support vendor management involved in R&D audit activities and ensure compliance with regulatory requirements.
2. Play a key role in defining, evaluating, and monitoring key performance indicators (KPIs) and drive key quality indicators (KQIs) for R&D auditing vendors, assisting with continuous improvement initiatives.
3. Review and/or approve required Auditing Documents related to the activities in scope.
4. Prepare, support, and follow-up on R&D (GCP and/or GLP) audits performed on behalf of the company by external vendors, ensuring alignment with internal audit processes and standards.
5. Provide management with summaries and analyses of quality risks and outcomes related to Auditing vendors activities.
6. External Auditing:
7. Contribute to the development of the risk-based GLP/GCP audit program through evaluation of internal quality system elements.
8. Perform GCP and/or GLP audits as per the annual audit program (investigator sites, vendors, systems, etc.).
9. Audit potential new vendors/partners for qualification prior to contractual relationships.
10. Manage findings, responses, and CAPAs arising from audits, escalating concerns to senior management as required.
11. Support preparations for critical Regulatory Authority inspections related to clinical activities.
12. Drive Insights for UCB through Data:
13. Ensure timely and accurate input of audit data in the Audit Management Tool.
14. Provide data and feedback to relevant internal stakeholders regarding Key Quality/Performance Indicators and quality compliance status.
15. Compliance Issues:
16. Escalate concerns and provide expert guidance on GCP/GLP compliance issues, supporting CAPAs and quality improvement measures.
17. Escalate critical compliance risks/issues to Global Quality Auditing Leadership.
18. Consulting, Educating, Quality Improvement, and External Focus:
19. Utilize knowledge of current business trends and regulations to influence quality approaches and ensure alignment with regulatory guidelines.
20. Participate in medium-long term projects within competence.
21. Perform other tasks within competence as requested by Global Quality Auditing Leadership.
The Skills and Knowledge Requirements
1. Substantial experience in the pharmaceutical/biotechnology area, particularly in GCP/GLP.
2. 3 years’ experience in leading GCP audits for internal and external processes.
3. Experience in GLP and/or GCLP-related areas.
4. Minimum of 3 years of auditing and 5 years in research and development, with vendor management experience as a plus.
5. In-depth knowledge of ICH-GCP, applicable regulations, and quality principles.
6. Knowledge of the Human Tissue Act and relevant regulations.
7. Foster a quality culture of shared accountability through teaching and coaching.
8. Knowledge of electronic systems in a regulated environment.
9. High level of personal integrity and commitment to patient welfare.
10. Fluent in written and spoken English; additional languages are a plus.
11. Able to travel nationally and internationally as business necessitates, averaging 20% of the time.
12. Demonstrated self-starter with a positive, action-oriented approach.
13. Confident presenter and communicator, able to engage various audiences effectively.
14. Skilled negotiator, able to influence and obtain cooperation during the audit process.
Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills.
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