Make your mark for patients
To strengthen our Quality systems & Strategy, we are looking for a talented profile to fill the position of: Computerized System Quality Assurance Lead – Braine l’Alleud, Belgium
About the role
The CSQA (Computerized System Quality Assurance) lead role at UCB ensures compliant GxP solutions for computerized systems and emerging technologies, benefiting UCB patients and improving the efficiency of UCB's quality systems. It also focuses on business continuity to improve GxP solutions compliance, risk identification, inspections, and day-to-day operational activities. Additionally, the CSQA lead is responsible for identifying, escalating, and mitigating data integrity compliance risks. This involves participating in projects to increase UCB's global data integrity maturity, monitoring progress, supporting related activities, and implementing data integrity controls.
You will collaborate with
The CSQA lead role collaborates with internal teams like IT, Early Solutions, Development Solutions, and vendors to ensure compliant GxP solutions and enhance UCB's quality systems. You will focus on computerized systems validation, data integrity, and new IT technologies, providing support during health authority inspections. The role has a global scope and may involve external parties to address quality, data integrity, and technology aspects in support of quality operations.
What you will do
1. Emphasize Collaboration and Communication: Collaborate with cross-functional teams and external partners to ensure data integrity and compliance. Create a positive work environment and promote a culture of data integrity.
2. Focus on Continuous Improvement: Promote continuous improvement of data integrity processes and digital technology systems by identifying and implementing best practices and innovative solutions. Keep the organization up-to-date with industry trends and regulatory updates. Regularly reviewing and refining processes ensures that data integrity standards are consistently met and improved upon.
3. Expand Training and Development: Develop or participate in training programs on validation principles, practices, and regulatory requirements for all GxP personnel. Build digital competencies across the QA organization.
4. Strengthen Leadership and Management Skills: Excellent leadership, managerial, and organizational skills. This includes the ability to lead and motivate staff in a matrix organization, manage numerous projects, and take an effective leadership position in group settings.
5. Enhance Regulatory Inspection Support: Provide support, consultancy, and guidance during health authority inspections in all digital and data integrity-related topics. This includes creating response strategies and defending related topics during interviews.
6. Improve Data Integrity Governance: Ensure robust data integrity governance processes are established and maintained, including data quality management, data lifecycle management, and data risk management. Identify gaps and develop appropriate mitigation plans.
7. Enhance Digital QA Expertise: Provide digital QA expertise and guidance, ensuring UCB develops GxP compliant digital solutions that support data integrity. This includes participating in projects across GxP disciplines supporting CSV (Computerized System Validation). Expertise in digital QA ensures that all digital solutions are designed and implemented with data integrity in mind.
8. Monitor Industry Trends: Continuously monitor industry trends and regulatory updates related to data integrity & digital technology to ensure that the organization's practices remain compliant.
9. Escalation Point for Validation & Data Integrity Issues: Serve as the primary escalation point for major or critical validation, digital technology and data integrity issues to ensure they are managed in line with current expectations.
10. New Technologies: Embrace the application of new technologies and solutions (AI/ML, SaaS…) in a compliant, efficient and structured way, while at the same time ensuring that all data generated, processed, and reported within the organization through those systems across the GxPs (GMP/ GDP, GCP, PhVP and GLP) are in accordance with the data integrity principles.
Interested? Here’s what you’ll need for this position:
* Bachelor’s or master’s degree in a relevant scientific discipline
* At least 7 years of experience in a pharmaceutical regulated environment
* At least 5 years of experience in a quality assurance role for computerized systems/applications
* Fluent English communication (oral and written); any additional languages are a plus
* Comprehensive knowledge of the pharmaceutical industry, including interpreting and applying relevant regulations
* Effective influencing skills to guide individuals without direct reporting relationships
* Ability to effectively manage multiple projects simultaneously
* Excellent stakeholder management and organizational skills
* Ability to lead and motivate staff as a line manager
* Professional maturity in handling stressful situations or conflicts
* Effective leadership in group settings, guiding and inspiring team members, fostering collaboration, and maintaining focus on collective goals
* Proficiency with Veeva systems is highly beneficial and will significantly enhance your ability to excel in this role
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.
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