Global Quality Auditing Lead - REMS​/GVP & GCP

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Raleigh, NC, Atlanta, GA or Boston, MA

The Global Quality Lead for REMS/GVP & GCP programs will co-create and implement the strategy and delivery of a risk based audit program covering the quality and compliance of the UCB REMS (Risk Evaluation & Mitigation Strategies) and Clinical Trials programs. They are responsible for providing input to processes and areas impacted by REMS, Good Pharmacovigilance Practice (GVP) and Good Clinical Practices (GCP) with respect to the requirements of global and local regulations, guidelines and industry best practice.

We are looking for a Global Quality Auditing Lead REMS / GVP & GCP to join our Global Quality Auditing team based out of Raleigh, NC, Atlanta, GA or Boston, MA

The Global Quality Lead for REMS/GVP & GCP programs will co-create and implement the strategy and delivery of a risk based audit program covering the quality and compliance of the UCB REMS (Risk Evaluation & Mitigation Strategies) and Clinical Trials programs. They are responsible for providing input to processes and areas impacted by REMS, Good Pharmacovigilance Practice (GVP) and Good Clinical Practices (GCP) with respect to the requirements of global and local regulations, guidelines and industry best practice.

This individual will work closely with UCB’s Global Quality Auditing team and interface directly with representatives from Regulatory Authorities across the world in association with inspections of the REMS/Pharmacovigilance System and Clinical Practices.

• Lead and/or participate in the development of the risk based REMS & GCP audit program through evaluation of elements of the UCB quality system and their effect on the overall state of compliance of the system.
• Plan, conduct, and report on REMS audits of Specialty Pharmacies (SPs), Specialty Distributors (SDs) and program vendors as well as internal system audit to assess compliance with REMS requirements
• Perform qualification PV audits of potential new vendors/partners/ Specialty Pharmacies (SPs), Specialty Distributors (SDs) and Coordinating Centres (CC).
• Perform GCP audits of potential new vendors/partners for purposes of qualification prior to contractual relationships.
• Proactively manage audit findings 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.
• Manage external auditors and/or vendors as required, ensuring that findings from pharmacovigilance audits are distributed, and responses and CAPAs are tracked and followed up as necessary in the Audit Management Tool.
• Support the preparation, hosting and follow up of Regulatory Authority inspections related to REMS/pharmacovigilance and clinical activities at the site inspected, in collaboration with the R&D Quality Management team.
• Through active participation to several forums (eg PV Quality Council…) and through direct interaction with colleagues, elevate concerns and provide expert guidance on PV and GCP compliance issues to support the development and implementation of necessary CAPAs and quality improvement measures.
• Utilize in-depth knowledge and understanding of current business trends, applicable regulations and quality principles, to collaborate effectively and influence approaches to quality, ensuring work products and output are aligned with regulatory guidelines.

• Bachelors Degree required
• 3+ years auditing experience in the relevant GVP/REMS-GCP area
• 10+ years in the pharmaceutical environment
• In-depth knowledge and understanding of REMS/Pharmacovigilance and ICH-GCP, applicable regulations (domestic and international), quality principles, relevant business processes and techniques.
• Understanding of regulatory requirements for the implementation and maintenance of a REMS compliance program
• Practical application of US FDA regulatory requirements
• Fluent in written and spoken English.…