Quality BCM Lead

Il y a 22 heures

Brainel'Alleud, Wallonia, Belgique UCB Temps plein
Make your mark for patients To strengthen our Global Quality
- Digital Quality Industrialization department, we are looking for a talented profile to fill the position of: Quality Business Continuity Lead & Process Data Owner – Braine l’Alleud, Belgium.

About the role
The Quality Continuity Management Lead is responsible for driving Business Continuity Management (BCM) activities across Global Quality, ensuring the resilience and recoverability of critical quality processes, systems, data, and regulatory operations during business disruptions. In addition, the role acts as Process Data Owner (PDO) and/or Functional System Owner (FSO) for designated Digital Quality solutions, providing business leadership to ensure systems remain compliant, validated, fit-for-purpose, and aligned with business and regulatory requirements. You will work with You will be closely working with Quality, Digital Technology, and business stakeholders. This position supports operational resilience, inspection readiness, and Digital Quality Transformation through effective continuity management and digital system stewardship. What you will do Business Continuity Management Â
· Act as the primary Business Continuity Management representative for Global Quality, ensuring alignment with Enterprise BCM governance, standards, methodologies, tools and resilience requirements. Â
· Support Quality process owners in the development, maintenance, and periodic review of Business Continuity Plans (BCPs) and Business Impact Analyses (BIAs) for critical Quality activities, processes, systems, and services. Â
· Coordinate continuity risk assessments and ensure key threats, vulnerabilities, dependencies, and recovery priorities are identified and appropriately addressed through appropriate mitigation and remediation plans. Â
· Drive the prioritization, follow-up, and closure of identified BCM gaps, mitigation actions, and risk remediation plans through Quality governance processes. Â
· Act as the BCM coordination point for Global Quality during continuity events, exercises, or BCM activations, ensuring effective communication and stakeholder alignment. Â
· Coordinate BCM exercises critical Quality Processes, simulations, and recovery testing activities, ensuring lessons learned and improvement actions are documented and tracked to completion. Â
· Ensure BCM compliance, audit readiness, inspection readiness, and maintenance of BCM documentation, records, and reporting metrics. Â
· Foster a culture of resilience and continuous improvement by partnering with Enterprise BCM, Quality stakeholders, Digital Technology, and Risk Management communities to strengthen organizational preparedness and recovery capabilities. Process Data Owner (PDO) / Functional System Owner (FSO) Â
· Act as Process Data Owner (PDO) and/or Functional System Owner (FSO) for assigned Quality digital solutions. Â
· Collaborate with Corporate Process Owners, Digital Technology System Owners, business stakeholders, and vendors to ensure digital solutions effectively support Quality processes and business objectives. Â
· Provide business stewardship and lifecycle management for assigned solutions, including deployment, adoption, validation, enhancements, integrations, change management, and continuous improvement. Â
· Ensure assigned digital solutions remain compliant, validated, fit-for-purpose, and aligned with applicable Quality, GxP, Data Integrity, and regulatory requirements. Â
· Maintain business requirements, governance documentation, SOPs, and associated Quality records, while supporting audits, inspections, deviations, investigations, CAPAs, and change controls. Â
· Drive innovation, reporting capabilities, data-driven decision-making, and adoption of emerging technologies, including AI-enabled solutions, to improve efficiency, compliance, and business value. Interested? For this position you’ll need the following education, experience and skills Â
· Bachelor’s or master’s degree or an education in a relevant scientific discipline Â
· Minimum 5 years of experience in Quality, GxP, Business Continuity, Digital Quality, Regulatory Compliance, or related areas within the pharmaceutical, biotechnology, medical device, or healthcare industries. Â
· Experience with computerized system lifecycle management, validation, or digital transformation initiatives. Â
· Experience in Business Continuity Management and operational resilience programs. Exposure to BCM frameworks (e.g., ISO 22301) and regulatory compliance requirements is a plus. Â
· Experience with Business Impact Analysis (BIA), risk assessments, and continuity planning/exercises. Â
· Familiarity with BCM tools or platforms and basic data analysis (Excel, Power BI, etc.) is a plus. Â
· Experience with Veeva Vault, Quality Management Systems, or equivalent regulated platforms is highly desirable Â
· Strong interest in emerging technologies, digital transformation, and Artificial Intelligence, with a proactive mindset to identify opportunities for improving efficiency, quality, compliance, and business value through innovative solutions. Â
· Demonstrated ability to analyze complex situations, assess risks and business impacts, identify opportunities for improvement, and implement practical, risk-based solutions and corrective actions. Â
· Strong leadership, communication, influencing, and negotiation skills with the ability to effectively engage cross-functional teams, senior leadership, regulatory authorities, and external partners in multicultural and virtual environments. 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 over 9.000 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 equal 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. At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office. UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws. 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.