Global Quality Auditing Outsourcing R&D Lead
‘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 is by this means ensuring that clinical trials are managed in compliance with regulatory requirements, contractual agreements, as well as company’s Global Quality Management System; and that compliance risks are appropriately identified and mitigated.
The Responsibilities
- 1. External Auditing vendor management
- Support vendor management involved in R&D audit activities and ensure compliance with regulatory requirements.
- Play a key role to assist in defining, evaluating, and monitoring key performance indicators (KPis) and drive key quality indicators (KQis) for R&D auditing vendors, and assisting with continuous improvement initiatives relating to management of vendors.
- Review and/or approve required Auditing Documents related to the activities in scope.
- Prepare, support and follow-up on R&D (GCP and/or GLP) audits performed on behalf of the company by external vendors, as per established process, contracts, and procedures. Ensure that execution of outsourced audits is conducted and completed in alignment with internal audit processes and standards. This also includes the appropriate oversight of vendors performing audits on behalf of the company.
- As required, provide management with a summary and analysis of quality risks and outcomes related to Auditing vendors activities.
- 2. External Auditing:
- Contribute and/or participate in the development of the risk based GLP/GCP audit program through evaluation of elements of the internal quality system and their effect on the overall state of compliance of the system.
- Perform GCP and/or GLP audits as per annual audit program (investigator sites, vendors, systems, … according to established audit strategy).
- Perform GCP and/or GLP audits of potential new vendors/partners for purposes of qualification prior to contractual relationships.
- Proactively manage findings, responses and CAPAs arising from audits in the Audit Management Tool, using all reasonable efforts to obtain prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to senior management.
- Support the preparation, hosting and follow up of critical Regulatory Authority inspections related to clinical activities, in collaboration with the R&D and PV Quality team.
- 3. Drive Insights for UCB through Data:
- Ensure timely and accurate input of audit data in Audit Management Tool.
- Contribute data and feedback to GCP/GLP-relevant internal stakeholders in UCB (e.g. Global Clinical Science and Operations, Global Clinical Development, Development Rare Disease, etc.) relating to Key Quality/Performance Indicators and quality compliance status.
- 4. Compliance Issues:
- Through active participation to several forums and through direct interaction with colleagues, escalate concerns and provide expert guidance on GCP/GLP compliance issues to support the development and implementation of necessary CAPAS and quality improvement measures.
- Escalate Critical Compliance risks/issues to Global Quality Auditing Leadership.
- 5. Consulting, Educating, Quality Improvement, and External Focus:
- Utilize in-depth knowledge and understanding of current business trends, applicable regulations, and quality principles, to collaborate effectively and influence approaches to quality, and ensure work products and output are aligned with regulatory guidelines, ICH/GCP, GLP regulations, other applicable regulatory requirements, and the company global quality standards.
- Participate in medium-long term projects within competence.
- Upon the request of/with the approval of Global Quality Auditing Leadership, perform other tasks within competence (as determined by relevant training, experience and/or qualifications).
The Skills and Knowledge Requirements
- Substantial and broad-ranging experience in the pharmaceutical/biotechnology area including significant time working in GCP/GLP related areas.
- 3 years’ experience in leading full range of GCP audits for internal processes/units and external partners or vendors, with depth of understanding of the theory and practice of quality management.
- Experience in the pharmaceutical/biotechnology area including time working in GLP and/or GCLP-related areas.
- Minimum of 3 years of auditing and 5 years overall dealing with research and development area. Experience in vendor management is a plus.
- In-depth knowledge and understanding of ICH-GCP, applicable regulations (domestic and international), quality principles, relevant business processes and techniques. Able to apply theoretical knowledge in practical situations.
- knowledge and understanding of Human Tissue Act and the Human Tissue Authority (HTA) codes of practice, GLP, GCLP, Good Research Practices and their applicable regulations (domestic and international), quality principles, relevant business processes and techniques.
- Fosters a quality culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching and coaching others.
- Knowledge regarding the use of electronic systems in a regulated environment, and personal functional computer literacy
- High level of personal integrity with a strong commitment to patient welfare and ethical behavior.
- Fluent in written and spoken English. Additional language skills would be an advantage.
- Able to travel nationally and internationally as business necessitates,20% of time on average.
- Demonstrated self-starter, highly reliable, with positive, action oriented, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by management and willingness to accept responsibility.
- Confident presenter and communicator, able to give presentations to interdepartmental audiences and represent company with externals and deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients.
- Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management during 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. We'll be your career partner every step of the way. If you are interested, you can send your CV to [email protected] .
