R&D and Pharmacovigilance Systems and Technology Lead

Job title:

R&D and Pharmacovigilance Systems and Technology Lead

Company:

UCB

Job description

Make your mark for patientsTo strengthen our R&D and Pharmacovigilance Quality we are looking for a talented profile to fill the position of: R&D and Pharmacovigilance Systems and Technology Lead – Braine l’Alleud, BelgiumAbout the roleAs a member of the UCB Quality organization, the R&D and PV Systems and Technology lead will support or lead strategic Digital Technology and Data initiatives aimed at augmenting decision-making, to help increase human capacity to make decision by generating data-driven insights. Besides helping to ensure the integrity of data, the role will focus on compliance with regulations and industry standards.You will work withThe R&D and PV Systems and Technology Lead will work within the UCB Quality organization, collaborating with global teams to support or lead strategic digital technology and data initiatives. The lead will also work closely with various business areas and strategic digital program leaders to support digital technology initiatives, develop project roadmaps, and conduct program reviews. Additionally, the role includes collaborating with teams to ensure quality by design, support computerized system validation activities, and maintain data integrity through assessments and training.What you will doEnsure GxP (i.e. GLP, GCP and GVP) business systems and technologies are fully regulatory compliant and meet digital technology strategy needs :

• Delivers and maintains the GLP, GCP, GVP compliance framework, industry best practices and relevant user requirements
• Participates in Regulatory Intelligence Network assessment of new/changes to existing legislation and guidance. Advises on actions required to impacted procedures and systems

Support digital technology initiatives to augment decision-making, i.e. to help increase human capacity to make decisions by generating data-driven insights:

• Stay abreast of digital innovation/technology needs and business priorities
• Participate in the definition of the data and digital strategy and in the establishment of individual project roadmaps.
• Participate in the identification, deployment and/or development of digital solutions.
• Support the set up and maintenance of detailed program and project roadmaps and interactions.
• Conducts or coordinates programs and projects reviews with the appropriate business area and related strategic digital program leaders

To ensure quality by design and a continuous state of inspection readiness:

• Identifies /develops and maintains metrics and KPI
• Reports on program process, issues and achievements.
• Lead/support system/technology-related risk identification and mitigation;
• Lead/support system-related preparation for vendor assessments, regulatory inspections/internal audits.

Support Computerized System Validation (CSV) activities:

• Maintain business QA CSV book of work activities for GLP, GCP and GVP-related systems.
• Participate in CSV activities.

Be a QA expert in the domain of data integrity and data analytics:

• Participate in assessments of projects
• Develop and provide training relating to area of responsibilities, industry innovation, DI and data analytics.

Data Integrity:

• Support Data Integrity Initiatives
• Support Mapping of data generation flow of various systems and assess data robustness

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 or IT/Engineering
• Fluent English communication (oral and written); any additional languages are a plus
• Prior experience in Pharmaceutical Research & Development (sponsor or CRO) is required with preferably 10 years total experience in one or more of the following areas: building quality assurance into systems operations processes, building practical implementation of regulatory and quality expectations into operations, business quality operations review of computerized system validations, process data owner of a regulated system
• Knowledge of GCP, GLP and GVP regulations
• Experience in managing non-compliance, system-related inspection readiness and CAPA management in at least one of the GxPs.
• Experience in the management of GLP/GCP and/or GVP system audits and inspections is an asset
• Knowledge of Health authority system compliance regulations and regional specificities (i.e. US, EU, Japan, China)
• Knowledge in data analytical tools (i.e. phyton, SAS, PowerBI) and business systems like CTMS, TMF, Safety, IRT, Clinical Trials, Clinical Data Management, Precision Medicine and Records Management
• Ability to analyse data, perform trend analysis and lead meaningful discussions with business management for meeting compliance requirements
• Familiarity with ICH E6 R3 and risk management
• Possesses a strong analytical mindset, with extensive experience in analyzing and synthesizing complex data, allowing for thorough and insightful evaluations.
• Capable of presenting complex projects and issues in a clear and succinct manner, making them easily understandable for various stakeholders.
• Expert in managing cross-functional quality optimization projects, with a proven ability to drive issue resolution for complex matters, ensuring effective outcomes
• Demonstrates excellent planning and organizational skills, enabling efficient management of tasks and resources

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.

Expected salary

Location

Braine-l’Alleud, Brabant Wallon

Job date

Sat, 01 Feb 2025 07:33:01 GMT

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