Expert in GLP/GCP Quality Assurance

仕事内容

Make your mark for patientsWe are looking for an Expert in GLP/GCP Quality Assurance to support all development phases of UCB compounds, to join our team in Braine l’Alleud, Belgium.About The RoleAs part of the Global Quality Assurance Organization, the Early & Clinical Development Quality Lead (ECDQL) is responsible to create value, by providing quality directions and insights that protect patients, sustain compliance, including driving inspection readiness activities aiming for real-time readiness, and preserve UCB’s reputation.The ECDQL will focus on driving quality and compliance in the early and clinical development phases of UCB compounds, from candidate selection to life cycle management, at a global level and in partnership with the Early Solutions and Development Solutions organizations and external stakeholders.The ECDQL serves as a key partner for the overall early and clinical development strategy at a compound level, in support of Sr R&D Leadership to develop and shape the future portfolio strategy as well as to align for execution and implementation.Who Will You Work WithReporting to the ECDQL - Data Management, Statistical Sciences and Digital Lead’, you will be a member of compound development teams, support study teams and teams that focus on data management, statistical science, and digital initiatives.What will you do?Develop and Maintain the Development Quality Strategy at a Compound level

• In support of the development and regulatory strategies and value dossiers and in close collaboration with internal business partners, develop and maintain a strategic quality roadmap/plan to execute on specific strategic initiatives that will deliver the long-term development strategy, and to document e.g. critical to quality parameters and measures (to be) taken applicable to all development phases for the assigned compound(s), in consideration of systems applied and vendors involved.
• Seek opportunities at a compound level aimed at establishing research/study design and vendor oversight that is fit for purpose, with focus on pro-actively ensuring the quality of downstream regulatory documentation, but also at the level of the systems and solutions applied to support developmental activities.
• Contribute to the risk mitigation program established for UCB clinical programs, prospectively identifying critical quality risk factors, their potential impact, and developing efficient processes or solutions to manage the risks.
• Focus on ensuring consistency and reducing complexity while ensuring GxP regulations, guidance and internal procedures are adhered to.
• Provide strategic input and quality expertise to management reviews at an asset level, including scenario development, trade-off implications and the evaluation/ assessment of opportunities.
• Consolidate input from within and outside the compound development team and functional areas to ensure all views are represented.
• Ensure collaboration and alignment with partners for successful execution.
• Incorporate deep internal and external insights on the long-term view of healthcare and the pharmaceutical industry.
• Strategically partner with the Global Quality Lead and Devices Quality Lead for the corresponding compounds, ensuring CM&C / Devices Quality constraints impacting Early and Clinical Development of the Compound are well integrated, and vice versa.

Pro-actively identify opportunities to de-risks at a compound level, across the development phases

• Independently plan, coordinate and execute quality activities (e.g. data review, spot checks) in accordance with the risk mitigation plans to validate the systems and processes established to ensure subject safety and protection and to ensure that clinical trials are performed and data are generated in adherence with the study protocol, targeted endpoints and in compliance with regulations.
• As required, review and coordinate the output of trends from audits and risk analyses prepared by colleagues, providing senior management and peers in other departments with a summary and analyses of the comparative risks and outcomes across multiple clinical programs.
• Leverage internal stakeholders and SME network to develop appropriate action plans, decisions and ensure efficient actions are taken to ensure compliance.
• Lead and/or provide input in complex and important matters or projects, initiated by business partners or a Global Quality function.
• Lead or support GLP/GCP (or GxP) inspection readiness.

Monitor the performance of (quality) systems and solutions and the quality of data that enables key decisions

• Conduct moderate to complex analytics and qualitative assessments to deliver insights, independently from the business or other quality functions.
• Advise on any measures to ensure continuous inspection readiness, high-quality regulatory dossiers, and strong value propositions.
• Monitor the quality performance of strategic vendors, specialty vendors, co-development, and licensing partners for assigned compounds, across the development phases.
• Ensure issues are escalated early and followed up until closure and/or effective measures are in place.
• Share regular updates with internal Partners to inform them of the results of the Quality Strategy applied for the Compound.
• Develop and/or review procedural documents relating to ECDQ activities.
• Review procedural documents maintained by business partners and provide valuable feedback.
• Lead, support and/or function as a liaison during inspections and investigations conducted by international and national authorities or business partners, including responsibility for the preparation, hosting of GLP/GCP inspections and the coordination of timely responses. Lead Rapid Response Teams to execute preparation, hosting and follow-up strategies.
• Provide input in risk assessment strategies that determine the GLP and GCP audit program including vendors, systems and investigational sites and in tactical, routine or for-cause GxP audit plans.
• Propose and lead Quality Optimization Initiatives based on identified signals/trends/risks relating to systems/processes and vendors, to pro-actively ensure quality and compliance, including the promotion of end-to-end quality.
• Particularly on the Early Development side, perform the regulatory required audits of the GLP study files, and risk-based assessment of the non-GLP research reports review.

As GCP/GLP/GxP Quality Advisor

• Coordinate and contribute to the review of new or updates to existing GxP legislation relating to the management of early and clinical development activities, define best practices and advise on practical implementation.
• Provides expert advice on clinical matters and partners with internal/external stakeholders to identify and mitigate compliance risks and (potential) observations.
• Utilize in-depth knowledge and understanding of current business trends, applicable regulations and quality principles, to collaborate effectively and influence approaches to quality, and ensure work products and output are aligned with regulatory guidelines, ICH-GCP, other applicable regulatory requirements and UCB global quality standards.
• Represent Early & Clinical Development Quality at interdepartmental and project team meetings taking the leadership role when required and dealing with complex and difficult or important project issues.
• Deliver presentations to peers, senior management, and industry audiences, acting as a role model for change.
• Providing mentoring and guidance to other members of the Early & Clinical Development Quality team, global quality and business partners.

In addition to the above, as Data Management, Statistical Sciences and Digital Quality Lead, the incumbent is responsible to:

• In partnership with internal stakeholders,
• Perform an independent review of documentation relating to statistical analysis programs for the development of all assets on the basis of the SAP and other documents (Protocol, CRF, DMM, ISAP, DAP and ASD), in consideration of UCB procedures and CRO activities
• Review the specification documentation for dataset (SDTM and ADaM), pooled datasets, TFLs and associated metadata
• Assess if the quality of study datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation meet standards requirements of regulatory agencies and other departments within UCB, prior to submission
• Ensure compliance with the 21 CFR Part 11 regulations.
• Advise on data integrity principles to be applied to support data use across the R&D organization at UCB., throughout a compound’s lifecycle, aimed at:
• Supporting accurate data insights and decisions from the set-up of data collection methods, the programming and analysis of a clinical study phases until the submission of data to regulators, e.g. as part of a regulatory dossier,
• Ensuring regulatory compliance (e.g. general data privacy and data protection regulation), across all compounds and studies, in collaboration with the ECDQL assigned to the compound.
• Support the validation of computerized systems and other digital initiatives.
• Support the UCB Data Governance framework.

Interested? For this position you’ll need the following education, experience, and skills:

• Master’s Degree in Computer Science, Mathematics, Statistical Programming (or a Master’s Degree in a Scientific field combined with a vast experience in statistical programming within the Biotechnology or Pharmaceutical Industry (including clinical research organizations).
• Excellent understanding and profound knowledge of statistical programming aspects required for regulatory submissions. Experience working in R and Python is an advantage.
• At least 5 years of experience working in the (bio)pharmaceutical industry preferred, with a minimum of 3 years in the early and/or clinical development operational and/or quality domain.
• Proficient in GCP regulations, applicable technical aspects and regional specificities.
• Ability to translate regulatory and quality expectations into operations based on experience and knowledge of quality principles.
• Expertise in Neurology, Immunology and Advanced Therapeutic Medicinal Products preferred.
• Experience in GLP and/or GCP quality auditing, inspection management and Medical Device regulations/operations is an asset.
• Experience in other GxP areas (GVP, GMP, GDP, GLP) is an asset.
• Experience in assessing R&D process requirement to successfully drive efficiency, optimization, and process improvement initiatives.
• Able to prioritize and focus on issues that matter most, based on a risk-based approach/solution.
• Manages quality and compliance issues respectfully, with diligence, rigor, within timeliness, and in all transparency.
• A strong analytical mind-set and experience in the analysis and synthesis of complex data
• Ability to present complex projects and issues in a clear succinct manner.
• IT: MS Office Suite and experience working with statistical programs, SAP, Veeva is an advantage.
• Excellent communication skills in English.

If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB .RANDATUCBAre 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 UsUCB 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 for 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.Learn more about sustainability at UCB and how it is integrated into our business approach.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/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.