Description du poste
Rejoignez UCB en tant que Responsable Conformité R&D et PV à Bulle. Cette opportunité vous place au cœur de l’innovation et de la qualité.TâchesAssurer la conformité réglementaire pour la sécurité des patients.Collaborer avec des partenaires internes et externes pour maintenir la qualité.Diriger des initiatives d’amélioration de la qualité au sein de l’organisation.CompétencesDiplôme en sciences de la vie; 10 ans d’expérience dans l’industrie pharmaceutique.Compétences en analyse de données et conformité réglementaire.Capacité à influencer et à collaborer dans un environnement matriciel.Make your mark for patientsTo strengthen our R&D and Pharmacovigilance Quality department we are looking for a talented profile to fill the position of: R&D and Pharmacovigilance Compliance Lead – Bulle, Switzerland.About the roleAs a member of the UCB Quality organization, the R&D and PV Compliance Lead ensures compliance with evolving laws and regulations to protect patients and uphold UCB’s reputation.The Compliance Lead supports stakeholders in investigating significant events, emphasizing quality by design, right-first-time practices, and inspection readiness during all development phases of UCB compounds globally. You will provide quality support, foster a culture of data-driven oversight, and lead cross-functional quality improvement initiatives.You will work withAs a member of the UCB Quality organization, the R&D and PV Compliance Lead will collaborate with a diverse range of stakeholders. This includes internal teams such as R&D, PV Quality, and other business units, as well as external partners like industry experts, and third-party vendors. By working closely with these groups, the Compliance Lead ensures that quality standards are met and maintained throughout the development and post-marketing phases of UCB compounds. This collaboration is essential for driving quality by design, ensuring right-first-time practices, and maintaining inspection readiness, ultimately protecting patients and preserving UCB’s reputation.What you will doPro-actively identify opportunities to de-risks at a system/vendor/partner level, across compounds and development phases· Plan and execute quality activities independently to ensure subject safety and data integrity, complying with regulations, procedures and contractual agreements.· Partner or Lead compliance investigations and ensure timely closure of corrective and preventive actions from assigned deviations, audits, and/or change control processes impacting regulatory processes.· Escalate issues early and ensure effective risk-based resolution are in place.· Leverage internal stakeholders and subject matter experts network to develop appropriate action plans, decisions and ensure efficient actions are taken to ensure compliance.Monitor the performance of (quality) systems and solutions and the quality of data to support oversight on critical to quality indicators and key decisions· Conduct analytics and qualitative assessments to identify trends and deliver insights.· Monitor the quality performance of UCB processes, strategic vendors and partners.· Review and coordinate the output of business trends from deviations, audits/inspections and risk analyses and provide senior management and relevant stakeholders with a summary and analyses of comparative risks and outcomes across multiple assets.Act as Quality Improvement Initiative Lead· Propose and lead Quality Improvement Initiatives based on identified signals/trends/risks relating to systems/processes and vendors, to pro-actively ensure quality and compliance including the promotion of quality throughout the product’s lifecycle, end-to-end. end-to-end quality.· Support initiatives to increase the quality culture.As Regulatory Compliance Quality Advisor· Review and implement updates to GxP legislations, define best practices and assess the impact on procedures, systems and contractual arrangements· Provide QA input during the creation and revision of UCB procedural documents to ensure GLP, GCP, and GVP compliance, or procedural documents under regulatory accountability (depending on the assignment).· Represent R&D and PV Quality at interdepartmental and project team meetings, as assigned.· Deliver presentations to peers, senior management, and industry audiences, as assigned.Interested? For this position you’ll need the following education, experience and skills· Bachelor’s Degree required; Master’s Degree preferred in Life Sciences Related Field.· Preferable 10 years of experience working in the (bio)pharmaceutical industry preferred, with a minimum of 5 years in the research, clinical development or Pharmacovigilance domain.· Proficient in research/GLP, GCP and/or GVP regulations and applicable regulatory framework.· Ability to translate regulatory and quality expectations into operations, based on knowledge of quality principles· Expertise in managing non-compliance, root-cause investigations and robust CAPA development in at least one of the GxPs.· Experience in leading transversal quality/process optimization projects, background in continuous improvement methodologies.· Ability to analyse data, perform trend analysis and lead meaningful discussions with business management for meeting compliance requirements.· Experience working with data analysis tools and notion of applying AI and Machine Learning in pharmaceutical industry.· Ability to drive collaboration and engagement across the stakeholder network, motivating others to achieve results· Skilled in influencing others within a global matrix organization and driving informed decision – making.· Manages quality and compliance issues with diligence, rigor, transparency and timeliness· Proficient in presenting complex projects and issues clearly and succinctly· Excellent planning, organizational, presentation, training, communication and interpersonal skills.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 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 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 onE-Mail schreiben. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel. Lire la suite
