UCB
Senior Process Quality Excellence Specialist
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We are looking for a Senior Process Quality Excellence Specialist who is collaborative, analytical, and quality-focused to join our Global Clinical Sciences and Operations team, based in our Slough, UK offices.
About the role
You will help strengthen the quality framework that supports global clinical study operations with the role focusing on supporting the GCSO functions with audits and inspections. You are going to report to the Head of Process Quality Excellence and maintain the audit and inspection enabler within the GCSO Quality Management System.
Who you’ll work with
You will work within Global Clinical Sciences and Operations functional teams and collaborate across Global Quality, Regulatory Affairs, clinical teams, strategic partners, and other internal and external stakeholders. You are going to share guidance, build effective working relationships, and bring the right people together to prepare, participate and support the resolution of any audit and inspection findings and subsequent CAPA’s. You will represent GCSO in audit and inspection discussions and be the first point of contact for GCSO colleagues.
What you’ll do
- Lead and drive GCSO Inspection Readiness Activities across all GCSO functions working closely with the relevant inspection team(s), if applicable.
- Participate in Audit and Inspection planning with Global Quality.
- Act as audit host for GCSO Internal Audits, if applicable.
- Represent or ensure GCSO representation including preparation during audits/inspections (on-site at UCB by internal and external parties) as applicable.
- Support GCSO staff with audit/inspection responses, where required.
- Support Corrective and Preventive Action (CAPA) activity for internal (system) audits and findings from any audits and inspections where findings are raised to UCB in conjunction with department managers and subject matter experts. This includes CAPA tracking and monitoring for timely closure.
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Interested?
For this position you’ll need the following education, experience, and skills:
- Bachelor's degree or equivalent relevant experience in life sciences, quality, clinical research, or a related field.
- At least eight years of pharmaceutical experience, preferably in global quality assurance, clinical quality management, or clinical operations.
- In-depth knowledge of GCP, ICH guidelines, and relevant international and local regulations for clinical study operations.
- Hands-on experience supporting or leading global GCP audits, inspections, inspection readiness, responses, and CAPA activities.
- At least one year's experience writing and revising SOPs, with strong planning, investigation, and root-cause analysis skills.
- Clear written and spoken English, with the ability to explain complex topics and collaborate effectively across cultures, functions, and seniority levels.
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!
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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 expressly 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 laws.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
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