Global Quality Auditing Lead - REMS/ GVP & GCP

Make your mark for patients

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

About the role

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.

Who you'll work with

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

What you'll do

• 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, escalate 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, and ensure work products and output are aligned with regulatory guidelines

Interested? For this role we're looking for the following education, experience and skills

• 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. Additional language skills would be an advantage.
• Able to travel nationally and internationally as business necessitates, 30% of time on average.

Preferred:

• Masters Degree strongly preferred
• Certification (Describe): ISO 9001 lead auditor certification as a nice to have, etc.)

This positions reasonably anticipated base salary range is $148,000-$195,000. The actual salary offered will take into account related knowledge, skills, experience and location among other factors and may fall outside the expected range.

Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless explicitly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.