Job Opportunities in Belgium
August 14, 2024
UCB
Braine-l'Alleud
OTHER
Clinical Supply QP Lead
Make your mark for patients
To strengthen our External and Clinical Supply Quality department we are looking for a talented profile to fill the position of Clinical Supply QP Lead – Braine l’Alleud, Belgium.
About the role
As the Clinical Supply QP Lead, you will oversee a team of Qualified Persons (QPs) within our Clinical Supply Quality organization. This team ensures the quality, safety and efficacy of investigational medicinal products (IMPs) for UCB-sponsored clinical trials.
Your main duties include managing batch disposition and release activities for IMPs, ensuring regulatory compliance, and acting as the Responsible Person (RP) according to Good Distribution Practices (GDP). You will also mentor and lead your team, setting an example for them. Additionally, you will support the Head of Clinical Supply Quality as their backup, providing essential expertise and assistance.
You will work with
As the Clinical Supply QP Lead, you will work closely with a team of Clinical Supply Qualified Persons (QPs) within the Clinical Supply Quality organization. You will also collaborate with cross-functional teams, vendors and internal stakeholders (Global Supply Chain) to ensure the quality, safety and efficacy of investigational medicinal products (IMPs) for UCB-sponsored clinical trials.
What you will do
Interested? For this position you’ll need the following education, experience and skills
Technical Expertise
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 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 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.
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/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
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.
To strengthen our External and Clinical Supply Quality department we are looking for a talented profile to fill the position of Clinical Supply QP Lead – Braine l’Alleud, Belgium.
About the role
As the Clinical Supply QP Lead, you will oversee a team of Qualified Persons (QPs) within our Clinical Supply Quality organization. This team ensures the quality, safety and efficacy of investigational medicinal products (IMPs) for UCB-sponsored clinical trials.
Your main duties include managing batch disposition and release activities for IMPs, ensuring regulatory compliance, and acting as the Responsible Person (RP) according to Good Distribution Practices (GDP). You will also mentor and lead your team, setting an example for them. Additionally, you will support the Head of Clinical Supply Quality as their backup, providing essential expertise and assistance.
You will work with
As the Clinical Supply QP Lead, you will work closely with a team of Clinical Supply Qualified Persons (QPs) within the Clinical Supply Quality organization. You will also collaborate with cross-functional teams, vendors and internal stakeholders (Global Supply Chain) to ensure the quality, safety and efficacy of investigational medicinal products (IMPs) for UCB-sponsored clinical trials.
What you will do
- Lead and manage the team of Clinical Supply QPs
- Oversee batch release activities, ensuring product quality, safety and efficacy
- Act as the Qualified Person (QP) for IMP batch release, adhering to regulations
- Manage quality systems for UCB products and services
- Resolve manufacturing issues and support during regulatory inspections
- Collaborate with cross-functional teams, vendors and stakeholders
- Drive quality improvement initiatives and foster departmental partnerships.
- Ensure compliance with EC GMP guidelines, Clinical Trials Regulation and Good Distribution Practices
- Provide GMP/GDP expertise through training and support compliance with regulations
- Contribute to audits, manage quality complaints and coordinate recalls
Interested? For this position you’ll need the following education, experience and skills
Technical Expertise
- Eligible to act as a QP in the Belgium territory with at least five years of practical experience in drug research and development or drug production quality management, including at least one year of drug quality management experience
- Extensive experience in a pharmaceutical regulated environment Knowledgeable in QA and pharmaceutical development processes
- Complete understanding of current regulatory requirements
- Experience in customer/vendor audits and regulatory inspections
- QA/compliance experience in IMP manufacturing and quality systems
- In-depth knowledge of a scientific discipline related to pharmaceutical sciences
- Excellent knowledge of c GMP and relevant regulatory requirements
- Strong interpersonal, verbal and written communication skills
- Maintain positive relationships with stakeholders
- Work effectively with minimal supervision
- Demonstrate teamwork, project management and organizational skills
- Fluent in English; French is a plus
- Facilitator, influencer, motivator and planner
- Drive and mentor your team, leading by example
- Fact-based decision-maker and strong decision-making skills
- Encourage continuous performance improvement and manages staff effectively
- Experience in failure investigations/root cause analysis
- Familiarity with risk analysis techniques
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 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 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.
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/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
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.
We regret to inform you that this job opportunity is no longer available
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