Rems Quality Operations Lead

Make your mark for patients

We are looking for a REMS Quality Operations Lead to join us in our Safety & Regulatory Quality Operations team based in Atlanta, GA or Raleigh, NC. Remote candidates may also be considered.

About the role
In a heavy regulated and dynamic environment this position is key in ensuring compliance and inspection readiness at UCB sites, following UCB’s Quality Management Systems, for Risk Evaluation and Mitigation Strategy (REMS) programs. Inspection readiness shall ensure UCB runs it operations in accordance with Health Authority (i.e., US Food and Drug Administration) issued guidance.

Who you’ll work with
The REMS Quality Operations Lead is a global, transversal role. The position requires close partnering, with senior leaders and functional Quality Management System Leads in the key stakeholder lines of pharmacovigilance, Global Medical Affairs and Global Regulatory Affairs, and other stakeholders to develop and maintain the Quality Management System and obtain a thorough understanding of potential areas of regulatory or safety risk.

What you’ll do

• Co-create, implement and/or support best in class business processes, with a clear focus on compliance to establish an enterprise-wide effect and fit for purpose safety related procedures.
• Pro-actively supporting and contributing to the life-cycle management of safety related procedures of key stakeholders by:
  • coaching colleagues in the fundamentals of process improvement (e.g., Six Sigma) and applicable regulations and how to implement such in a compliant and efficient manner.
  • provision of consultation, education and coaching, leading improvement initiatives in order to improve safety related processes and their effectiveness while being involved in the revision of safety related procedures.
  • supporting internal safety stakeholders in the management of audit/inspection related findings by aligning CAPA with the system improvement and/or product life cycle.
• Co-create and implements submission and post approval safety related inspection readiness activities by using change management strategies principles.
• Supporting internal safety stakeholders in the management of audit/inspection related findings by aligning CAPA with the system improvement and/or product life cycle.
• Collaborate and partner with key stakeholders to identify and mitigate Compliance risks, resolve potential regulatory observations, escalate critical Compliance risks to upper management, and leverage internal resources and SME network to develop appropriate action plans and decisions as needed.
• Conduct Quality operational activities as identified by the REMS project.
• Keep abreast of regulatory and industry regulations and trends.
• Provision of consultation, education and coaching, leading improvement initiatives in order to improve safety related processes and their effectiveness while being involved in the revision of safety related procedures.
• Provide input and advice on safety related processes, tools (e.g., Computerized System Validation) and areas impacted by safety with respect to the requirements of global and local regulations, guidelines and industry best practice such as Good Pharmacovigilance Practice (GVP).
• Coaching colleagues in the fundamentals of process improvement (e.g., Six Sigma) and applicable regulations and how to implement such in a compliant and efficient manner.

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

• Bachelors Degree
• In depth knowledge and understanding of Pharmacovigilance systems in the pharmaceutical industry and of applicable regulations, computerized system validation, GVP principles, and practice.
• Experience conducting and monitoring Quality operational activities for REMS programs.
• Experience in and having an in-depth of understanding of the theory and practice of quality management (e.g., ICH Q10 Quality Systems)
• Broad-ranging experience in the global environment of pharmaceutical/biotechnology area including significant time working on REMS programs and/or Pharmacovigilance related areas.
• Experience in leading range of global Pharmacovigilance related project, process improvement activities and in managing/hosting regulatory inspections or third-party audits

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 around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work for 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 equitable 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.

Learn more about sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.