To strengthen our Global QA Compliance Operationsdepartment, part of Internal Manufacturing Quality (IMQ) we are looking for a talented profile to fill the position of: Head Performance & Operational Excellence – Braine l’Alleud, Belgium.
About The Role
The Head of Performance, Operational Excellence is a senior position within the Quality Compliance Operations team, reporting directly to the Head of QA Compliance Operations.
The position focus will be to ensure Projects & Operational Excellence initiatives, Performance (KPIs) and continuous improvement across all internal manufacturing sites that include GMP/GDP MR and QSMR, Product complaint management, Product returns management, Escalation management, Recall management and Quality Alert management.
This strategic role ensures that Performance and Operational Excellence across individual operational sites in UCB are implemented in an aligned manner and maintained continuously to meet regulatory requirements and internal corporate standards.
While executing these Global activities the role needs to foster a culture of continuous improvement, process optimalization, driving operational excellence and implement process & value driven Digitalization, and collaborate with key stakeholders globally across UCB Units to uphold and enhance the organization’s quality standards.
You will work with
In this role, you will work closely with various stakeholders across UCB's internal and external manufacturing organizations. You will collaborate with the Internal Manufacturing Quality Assurance Leadership team, the QA Compliance Operations Leadership team ensuring alignment and harmonization of Continuous Improvement activities across all operational sites. Additionally, you will engage with the External Manufacturing organization to align processes. You will also interact with key stakeholders globally across UCB Units to foster a culture of continuous improvement, process optimization and wherever there is a process and value driven digitalization opportunity while supporting the organization’s quality standards.
What You Will Do
Lead a global quality team who supports operational and strategic activities, provide development opportunities while being value driven.
Lead Gemba sessions across UCB Sites/ Departments to understand existing quality processes part of the role and systems, identify inefficiencies and identify Value Digitalization when needed.
Drive the harmonization and standardization of operational processes and performance practices across internal and manufacturing sites, fostering efficiency and continuous improvement globally.
Lead Continuous Improvement initiatives aiming at enhancing efficiency, reducing risks, and maintaining high standards of compliance.
Set up an automated KPI monitoring system across the sites to track real-time Quality and Compliance performance of each site and establish leading indicators that can help predict focus areas in advance before potential issues arise.
Conduct monthly KPI reporting that include actionable items to drive continuous improvement.
Support the Head Audit and Inspection Readiness in managing risks and participating in audits and inspections when required.
Promote a culture of innovation and continuous learning within the team and across the organization.
Oversee the training matrix, onboarding and development of people within the team.
Serve as the transversal IMQ Single Point Of Contact (SPOC) for Quality Compliance topics below:
GMP/GDP MR and QSMR
Product complaint management
Product returns management
Recall management
Quality Alert management
Partner with key stakeholders to support ongoing requests and build regular networking communication (e.g. monthly meeting, monthly gemba...).
Integrate any new IM UCB site into global performance and operational excellence frameworks that include process optimization, capability building, implementation of digital tools for performance tracking and harmonization of operational standards to ensure efficiency and compliance
Interested? For this position you’ll need the following education, experience and skills
Bachelor’s, master’s degree or an education in a relevant scientific discipline
Minimum of 10 years in Quality Assurance or/and Quality Systems Operations or/and Quality Compliance within a regulated pharmaceutical environment or equivalent
Fluent English communication (oral and written); any additional languages are a plus
Deep understanding of cGMP principles and global regulatory environments
Proven track record in leading a team of people across the world
Experience in participating in audits and inspection (FDA)
Experience in Value driven Digitalization is a plus
PMO, green belt, lean & six sigma is a plus
Excellent organizational and analytical abilities to manage projects
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 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.
#J-18808-Ljbffr