Evidence Quality Lead

pbMake your mark for patients /b /ppTo strengthen our bGlobal /b bQuality Assurance /bdepartment, we are looking for a talented professional to fill the position of: bEvidence Quality Lead – Bulle -Switzerland. /b /ppbAbout the role /b /ppAs part of the UCB Quality organization, the Evidence Quality Lead (EQL) actively enables compliant Research, Development and Pharmacovigilance processes (i.e., GLP GCP GVP) from candidate to asset delivery, to commercial branding, with a focus on successful global launches and sustainable access for our patients. Collaborating with internal teams and external stakeholders, the EQL plays a crucial role in ensuring quality by design and maintaining continuous inspection readiness. /ppbYou will work with /b /ppYou will work closely with a variety of internal functions within Quality and the Business area’s you support. Additionally, you will engage with external partners and vendors to ensure the integrity of data for delegated activities. /ppbWhat you will do /b /ppDevelop and Maintain the Quality Strategy at a Compound Level /pliCreate and sustain a quality roadmap for strategic quality objectives, covering the clinical development and post-marketing phases, /liliIdentify and manage risks using a risk-based approach across compounds, processes, systems, sites, and vendors /liliEnsure compliance with GxP regulations, guidance, and internal procedures while reducing complexity /lipProactively Identify Opportunities to De-Risk at a Compound Level /pliPlan and execute quality activities independently to ensure subject safety and data integrity, complying with protocols and regulations /liliLead compliance investigations and ensure timely closure of corrective and preventative actions from deviations, audits and inspections /liliEscalate issues early and ensure effective resolution or measures are in place /liliLead or contribute to complex projects /liliManage pre-inspection documentation, quality reviews, in collaboration with functional SMEs and global process owners. /lipMonitor Performance /pliConduct analytics and qualitative assessments to identify trends /liliMonitor quality deliverables from vendors and partners, sharing updates with internal functions /liliEnsure continuous inspection readiness and integrity of the data included in regulatory dossiers /liliLead/support inspections and investigations, coordinating responses and hosting strategies /lipGxP Quality Advisor Responsibilities /pliReview and implement updates to GxP legislation, define best practices and assess the impact on procedures, systems and contractual arrangements /liliProvide expert advice to mitigate compliance risks or to address complex issues. /liliDeliver presentations to peers, senior management, and industry audiences /lipbr/bInterested? For this position you’ll need the following education, experience and skills /b /pliBachelor's degree in a relevant scientific or healthcare-related field /liliMinimum of 10 years in the (bio)pharmaceutical industry, with at least 5 years in research or clinical development /liliAt least 2 years expereince within the ATMP regulatory framework /liliFluent English communication (oral and written); any additional languages are a plus. /liliProven track record of contributing to gene therapy clinical programs with technical and scientific expertise /liliAbility to translate regulatory and quality expectations into operations, based on knowledge of quality principles /liliExperience in GLP, GCP and/or GVP quality auditing, inspection, compliance management, and/or Medical Device regulations/operations is an asset /liliAbility to drive collaboration and engagement across the stakeholder network, motivating others to achieve results /liliSkilled in influencing others within a global matrix organization and driving informed decision-making /liliCapable of prioritizing and focusing on critical issues using a risk-based approach /liliManages quality and compliance issues with diligence, rigor, transparency and timeliness /liliStrong analytical skills with experience in analyzing and synthesizing complex data /liliProficient in presenting complex projects and issues clearly and succinctly /lipAre 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! /p